ClearanceBrief
510(k) K012009 ยท JAK System, X-Ray, Tomography, Computed

MX8000 IDT CT SYSTEM

ApplicantMarconi Medical Systems, Inc., Cleveland OH, US
DecisionSubstantially Equivalent, Sep 13, 2001
ReceivedJun 27, 2001
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K012009

DateFirm and productCodeLinked 510(k)
Sep 19, 2025Philips 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
JAKNone listed
May 1, 2021Philips 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
JAKNone listed
Oct 18, 2018Philips 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
JAKNone listed
Oct 18, 2018Philips 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
JAKNone listed
Oct 18, 2018Philips 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
JAKNone listed
Oct 18, 2018Philips 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
JAKNone listed
Jul 3, 2018Philips 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
JAKNone listed
Mar 30, 2018Philips Medical Systems (Cleveland) Inc
Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system
Terminated
JAKNone listed
Mar 30, 2018Philips Medical Systems (Cleveland) Inc
Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system
Terminated
JAKNone listed
Feb 8, 2018Philips 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
JAKNone listed
Feb 8, 2018Philips 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
JAKNone listed
Jul 20, 2016Philips 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
JAKNone listed
Jul 20, 2016Philips 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
JAKNone listed
Mar 24, 2016Philips 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
JAKNone listed
Mar 24, 2016Philips 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
JAKNone listed
Mar 4, 2016Philips 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
JAKNone listed
Sep 14, 2015Philips Medical Systems (Cleveland) Inc
Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Terminated
JAKNone listed
Jun 11, 2015Philips 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
JAKNone listed
Jun 11, 2015Philips 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
JAKNone listed
Jun 11, 2015Philips 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
JAKNone listed
May 22, 2015Philips 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
JAKNone listed
May 22, 2015Philips 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
JAKNone listed
May 22, 2015Philips 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
JAKNone listed
May 22, 2015Philips 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
JAKNone listed
May 22, 2015Philips 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
JAKNone listed
Jan 15, 2015Philips 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
JAKNone listed
Aug 14, 2014Philips 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
JAKNone listed
Jun 4, 2014Philips 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
JAKNone listed
Jun 2, 2014Philips 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
KPSNone listed
Apr 16, 2014Philips 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
JAKNone listed
Oct 17, 2013Philips 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
JAKNone listed
Sep 16, 2013Philips 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
JAKNone listed
May 20, 2013Philips 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
JAKNone listed
Mar 13, 2013Philips 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
JAKNone listed
Feb 26, 2013Philips 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
JAKNone listed
Sep 25, 2012Philips 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
JAKNone listed
Sep 19, 2012Philips 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
JAKNone listed
Aug 22, 2012Philips 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
JAKNone listed
Jul 19, 2012Philips 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
JAKNone listed
Jul 12, 2012Philips 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
JAKNone listed
Jul 11, 2012Philips 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
JAKNone listed
Jul 11, 2012Philips 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
JAKNone listed
May 30, 2012Philips 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
JAKNone listed
May 30, 2012Philips 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
JAKNone listed
May 30, 2012Philips 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
JAKNone listed
May 30, 2012Philips 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
JAKNone listed
Nov 10, 2011Philips 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
LLZNone listed
Mar 24, 2011Philips 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
KPSNone listed
Mar 16, 2011Philips 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
KPSNone listed
Oct 22, 2010Philips 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
JAKNone listed
Jul 6, 2009Philips 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
KPSNone listed
Jan 16, 2009Philips 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
KPSNone listed
Oct 28, 2008Philips Medical Systems (Cleveland) Inc
Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Toolkit Oncology Pro, Model #455011203131 and Model #455011203191.
Terminated
KPSNone listed
Dec 29, 2007Philips 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
JAKNone listed
May 19, 2006Philips Medical Systems (Cleveland) Inc
Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and processing workstation, for CT images.
Terminated
LLZNone listed
Aug 30, 2005Philips 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
JAKNone listed
Aug 30, 2005Philips Medical Systems (Cleveland) Inc
Extended Brilliance Workspace using 1.x or 2.x software.
Terminated
JAKNone listed
Aug 30, 2005Philips Medical Systems (Cleveland) Inc
MxView using version 5.0, 5.0.1, or 4.1 software.
Terminated
JAKNone listed
Jul 20, 2004Philips Medical Systems (Cleveland) Inc
Philips MX8000 IDT CT Scanner System, 10 & 16 slice images.
Terminated
JAKNone listed
Jul 20, 2004Philips Medical Systems (Cleveland) Inc
Philips Brilliance CT Scanner System, 6, 10 & 16 slice images.
Terminated
JAKNone listed
May 15, 2003Philips Medical Systems (Cleveland) Inc
Philips MX8000 IDT CT Scanner, utilizing V2.1 software.
Terminated
JAKNone listed

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