510(k) K012009 ยท JAK System, X-Ray, Tomography, Computed
MX8000 IDT CT SYSTEM
| Applicant | Marconi Medical Systems, Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Sep 13, 2001 |
| Received | Jun 27, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012009
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2025 | Philips North America Llc Philips CT systems labeled as the following:
1. Brilliance 16 Power, Model Number: 728240.
2. Brilliance CT 16 Slice, Model Number: 728246.
3. Brilliance CT 6 Slice, Model Number: 728256. Open, Classified |
JAK | None listed |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems.
Brilliance 16 Power, Brilliance 16/10/6 Water/Air
728240/728245/728246 Open, Classified |
JAK | None listed |
| Oct 18, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 16 Slice (Power), Model 728240
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data Terminated |
JAK | None listed |
| Oct 18, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 16 Slice (Air), Model 728246
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data t Terminated |
JAK | None listed |
| Oct 18, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 10 Slice (Air), Model 728251
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data t Terminated |
JAK | None listed |
| Oct 18, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 6 Slice (Air), Model 728256
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data ta Terminated |
JAK | None listed |
| Jul 3, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 16 Air, 728246
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at differ Terminated |
JAK | None listed |
| Mar 30, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system Terminated |
JAK | None listed |
| Mar 30, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system Terminated |
JAK | None listed |
| Feb 8, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 16 Slice (Air) - Model no. 728246, Computed Tomography X-Ray system
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reco Terminated |
JAK | None listed |
| Feb 8, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 6 Slice (Air) - Model no. 728256, Computed Tomography X-Ray system
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer recon Terminated |
JAK | None listed |
| Jul 20, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance 16, Model number 728246
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken Terminated |
JAK | None listed |
| Jul 20, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance CT 16 Power, Model number 728240
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission da Terminated |
JAK | None listed |
| Mar 24, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Terminated |
JAK | None listed |
| Mar 24, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and p Terminated |
JAK | None listed |
| Mar 4, 2016 | Philips Medical Systems (Cleveland) Inc IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH.
Provides software applications used to process, analyze, and display medical images/data. Terminated |
JAK | None listed |
| Sep 14, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body. Terminated |
JAK | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
JAK | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
JAK | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Diamond Select Brilliance CT 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
JAK | None listed |
| May 22, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance CT 16 Power.
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and pl Terminated |
JAK | None listed |
| May 22, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance CT 16 Water.
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and pl Terminated |
JAK | None listed |
| May 22, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance CT 16 Air.
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and plan Terminated |
JAK | None listed |
| May 22, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance CT 10 Air.
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and plan Terminated |
JAK | None listed |
| May 22, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance CT 6 Air.
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and plane Terminated |
JAK | None listed |
| Jan 15, 2015 | Philips Medical Systems (Cleveland) Inc Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package
Product Usage:
Intended to produce cross-sectional images of the body by computer reconstruction of X-ray tran Terminated |
JAK | None listed |
| Aug 14, 2014 | Philips Medical Systems (Cleveland) Inc IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT
IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server Terminated |
JAK | None listed |
| Jun 4, 2014 | Philips Medical Systems (Cleveland) Inc Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners) Terminated |
JAK | None listed |
| Jun 2, 2014 | Philips Medical Systems (Cleveland) Inc IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imagin Terminated |
KPS | None listed |
| Apr 16, 2014 | Philips Medical Systems (Cleveland) Inc Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Terminated |
JAK | None listed |
| Oct 17, 2013 | Philips Medical Systems (Cleveland) Inc Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air)
Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are Terminated |
JAK | None listed |
| Sep 16, 2013 | Philips Medical Systems (Cleveland) Inc Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143.
Intended to produce cross-sectional i Terminated |
JAK | None listed |
| May 20, 2013 | Philips Medical Systems (Cleveland) Inc Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Slice Water, System Code: 728255; MX8000 IDT 16, System Code: 728120 & MX8000 ID Terminated |
JAK | None listed |
| Mar 13, 2013 | Philips Medical Systems (Cleveland) Inc Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems.
These devices are Computed Tomography X-Ray Systems that are int Terminated |
JAK | None listed |
| Feb 26, 2013 | Philips Medical Systems (Cleveland) Inc Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System. Terminated |
JAK | None listed |
| Sep 25, 2012 | Philips Medical Systems (Cleveland) Inc Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH.
The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Terminated |
JAK | None listed |
| Sep 19, 2012 | Philips Medical Systems (Cleveland) Inc The Brilliance CT 16 System
Product Usage:
The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ra Terminated |
JAK | None listed |
| Aug 22, 2012 | Philips Medical Systems (Cleveland) Inc The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components an Terminated |
JAK | None listed |
| Jul 19, 2012 | Philips Medical Systems (Cleveland) Inc Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems.
The devices are Computed Tomography Systems that are intended to produce cross-sectional images of th Terminated |
JAK | None listed |
| Jul 12, 2012 | Philips Medical Systems (Cleveland) Inc Intellispace Portal software
Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Terminated |
JAK | None listed |
| Jul 11, 2012 | Philips Medical Systems (Cleveland) Inc IntelliSpace Portal software and Extended Brillance Workspace software
Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical appli Terminated |
JAK | None listed |
| Jul 11, 2012 | Philips Medical Systems (Cleveland) Inc Intellispace Portal software.
Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Terminated |
JAK | None listed |
| May 30, 2012 | Philips Medical Systems (Cleveland) Inc Brilliance 16 - Model #728246, CT Scanning System is subject to recall/correction
Product Usage:
The Brilliance 6, 16, 40 64, Big Bore, iCT, iCT SP and Ingenuity CT are Computed Tomography X-Ray Syst Terminated |
JAK | None listed |
| May 30, 2012 | Philips Medical Systems (Cleveland) Inc Brilliance 40 - Model #72835, and Brilliance 64 - Model #728231, and Ingenuity - Model #728326, CT Scanning Systems are subject to recall/correction
Product Usage:
The Brilliance 6, 16, 40 64, Big Terminated |
JAK | None listed |
| May 30, 2012 | Philips Medical Systems (Cleveland) Inc Brilliance Big Bore - Model #728243, and - Model #728244, CT Scanning System is subject to recall/correction
Product Usage:
The Brilliance 6, 16, 40 64, Brilliance Big Bore, iCT, iCT SP and Ingen Terminated |
JAK | None listed |
| May 30, 2012 | Philips Medical Systems (Cleveland) Inc Brilliance iCT - Model #728306, and Brilliance iCT SP - Model #728311, CT Scanning System is subject to recall/correction
Product Usage:
The Brilliance 6, 16, 40 64, Brilliance Big Bore, iCT, iCT S Terminated |
JAK | None listed |
| Nov 10, 2011 | Philips Medical Systems Extended Brilliance Workstation-NM (EBW-NM)
with software version 1.0P, 1.1.1A, 1.5H, 1.5.1A and 2.0Q -Field Test Period
A nuclear medicine image display and processing application suite that provi Terminated |
LLZ | None listed |
| Mar 24, 2011 | Philips Medical Systems (Cleveland) Inc Extended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System Model Numbers EBW (CT) 728260 & EBW (Portal) 728269.
The Extended Brilliance Workplace (EBW) is a component o Terminated |
KPS | None listed |
| Mar 16, 2011 | Philips Medical Systems (Cleveland) Inc Vertical Brake Hubs of the Computed Tomography X-Ray Systems under the following Brands and Model #s: Brilliance 6, M/Ns 3001-3708, 30001-30131; Brilliance 10, M/Ns 4001-4067, 40001-40035 ; Brillianc Terminated |
KPS | None listed |
| Oct 22, 2010 | Philips Medical Systems (Cleveland) Inc Computed Tomography X-Ray System MX 8000 IDT 16; Model # 728120; Serial #'s: 2513, 2518, 3147, 3217, 3014, 3050, 3068, 3188, 3091, 3051, 3099, 3126, 3183, 3303, 2539 & 3056.
Produce cross-sectional im Terminated |
JAK | None listed |
| Jul 6, 2009 | Philips Medical Systems (Cleveland) Inc Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1. Model #455011202691 for Computed Tomography (CT); Model #455011002031 for Nuclear Medicine (NM).
The "Extended Brilliance Wor Terminated |
KPS | None listed |
| Jan 16, 2009 | Philips Medical Systems (Cleveland) Inc Vertical drive brake (on patient supports). Used on certain Philips Medical Systems MX series and Brilliance series CT scanners.
The device is a vertical drive brake that controls the vertical posi Terminated |
KPS | None listed |
| Oct 28, 2008 | Philips Medical Systems (Cleveland) Inc Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Toolkit Oncology Pro, Model #455011203131 and Model #455011203191. Terminated |
KPS | None listed |
| Dec 29, 2007 | Philips Medical Systems (Cleveland) Inc Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Gemini TFs, GXLs and EBW Workstations. Philips Medical Systems, Cleveland, OH 44143. (The product is a soft Terminated |
JAK | None listed |
| May 19, 2006 | Philips Medical Systems (Cleveland) Inc Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and processing workstation, for CT images. Terminated |
LLZ | None listed |
| Aug 30, 2005 | Philips Medical Systems (Cleveland) Inc Brillance 16, 10, and 6 configuration (watercooled version) using 1.0, 1.1, 1.2, 1.2.2, or 1.2.4 software. Terminated |
JAK | None listed |
| Aug 30, 2005 | Philips Medical Systems (Cleveland) Inc Extended Brilliance Workspace using 1.x or 2.x software. Terminated |
JAK | None listed |
| Aug 30, 2005 | Philips Medical Systems (Cleveland) Inc MxView using version 5.0, 5.0.1, or 4.1 software. Terminated |
JAK | None listed |
| Jul 20, 2004 | Philips Medical Systems (Cleveland) Inc Philips MX8000 IDT CT Scanner System, 10 & 16 slice images. Terminated |
JAK | None listed |
| Jul 20, 2004 | Philips Medical Systems (Cleveland) Inc Philips Brilliance CT Scanner System, 6, 10 & 16 slice images. Terminated |
JAK | None listed |
| May 15, 2003 | Philips Medical Systems (Cleveland) Inc Philips MX8000 IDT CT Scanner, utilizing V2.1 software. Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.