510(k) K033357 ยท JAK System, X-Ray, Tomography, Computed
ACQSIM-MULTISLICE-CT, MODEL 453567042271
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Jan 9, 2004 |
| Received | Oct 20, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033357
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.
BB (Big Bore) Oncology, BB (Big Bore) Radiology:
728242/728243/728244 Open, Classified |
JAK | None listed |
| Mar 28, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance Big Bore Radiology 728244 Terminated |
JAK | None listed |
| Feb 8, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray system
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer Terminated |
JAK | None listed |
| Feb 8, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by compute Terminated |
JAK | None listed |
| Jan 3, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer recon Terminated |
JAK | None listed |
| Jan 3, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer recons Terminated |
JAK | None listed |
| Feb 23, 2017 | Philips Medical Systems (Cleveland) Inc Brilliance BigBore Oncology CT - 728243
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at differen Terminated |
JAK | None listed |
| Feb 23, 2017 | Philips Medical Systems (Cleveland) Inc Brilliance BigBore Radiology CT - 728244
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at differe Terminated |
JAK | None listed |
| Jul 20, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance CT Big Bore Oncology, Model number 728243
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transm Terminated |
JAK | None listed |
| Jul 20, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance BigBore Radiology CT Model number 728244
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmi Terminated |
JAK | None listed |
| Jun 21, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body. Terminated |
JAK | None listed |
| Jun 14, 2016 | Philips Medical Systems (Cleveland) Inc Big Bore Oncology tomography X-ray system scanner, model number 728243.
The Big Bore Oncology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of th Terminated |
JAK | None listed |
| Jun 14, 2016 | Philips Medical Systems (Cleveland) Inc Big Bore Radiology tomography X-ray system scanner, model number 728244.
The Big Bore Radiology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of Terminated |
JAK | None listed |
| Mar 24, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance BigBore Oncology 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 an Terminated |
JAK | None listed |
| Mar 24, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance BigBore Radiology 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 a Terminated |
JAK | None listed |
| Dec 10, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visu Terminated |
JAK | None listed |
| Sep 14, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance Big Bore (Oncology & Radiology) 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 40 - Slices(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 Big Bore Radiology (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 Big Bore Oncology.
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 angl 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 |
| Sep 22, 2014 | Philips Medical Systems (Cleveland) Inc No packaging. The device is a computed tomography scanner.
Intended to provide corss sectional images of the human body and visualization of the internal organs of the body. Terminated |
JAX | None listed |
| Sep 18, 2014 | Philips Medical Systems (Cleveland) Inc The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from the same a Terminated |
JAK | None listed |
| Jun 22, 2014 | Philips Medical Systems (Cleveland) Inc Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System.
Product Usage:
The Brilliance CT Big Bor 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 |
| 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 |
| Jan 29, 2014 | Philips Medical Systems (Cleveland) Inc Brilliance iCT, Brilliance 64 and Brilliance Big Bore
The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the Terminated |
JAK | None listed |
| Jan 21, 2014 | Philips Medical Systems (Cleveland) Inc Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH.
Produces cross-sectional body images by 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 |
| 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, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244. 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 |
| 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 |
| Feb 3, 2012 | Philips Medical Systems (Cleveland) Inc Brilliance Big Bore Model #728243 and #728244, Philips Medical Systems.
Computed Tomography X-Ray System intended to produce of x-ray transmission data taken at different angles and planes. Terminated |
JAK | None listed |
| Jan 24, 2012 | Philips Medical Systems (Cleveland) Inc Computed Tomography X-Ray Systems (Brilliance 64, Model Number: 728231; Brilliance Big Bore, Model Number: 728243; Brilliance iCT, Model Number: 728306; Brilliance iCT SP, Model Number: 728311; and In Terminated |
JAK | None listed |
| Jan 17, 2012 | Philips Medical Systems (Cleveland) Inc Brilliance Big Bore CT (Computed Tomography) System, 510 (k) #K033357, Model #728243, Serial Numbers: 7006, 7154, and 7349. The recalled CT systems are equipped with Software Version 3.5 Beta 2.
Pro Terminated |
JAK | None listed |
| Dec 1, 2011 | Philips Medical Systems (Cleveland) Inc Brilliance Big Bore Computed Tomography X-Ray System, 510(k) #K033357, Model Number: 728243, Serial Numbers: 7298, and 7060. The recalled device systems are equipped with Version 3.5 Beta 1 softwar Terminated |
JAK | None listed |
| May 19, 2011 | Philips Medical Systems (Cleveland) Inc Brilliance Big Bore Computed Tomography X-Ray System, Model Number: 728243. The units subject to correction are equipped with software version: 3.5.17030.
Intended to produce cross-sectional imag Terminated |
JAK | 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 |
| Nov 17, 2009 | Philips Medical Systems (Cleveland) Inc Respiratory Gating System, Catalog #NPTA540, Model #4535 674 26701, which includes: Pulmonary digital assembly kit and Pulmonary toolkit oncology Pro available on the following GEMINI PET/CT systems Terminated |
JAK | None listed |
| Nov 17, 2009 | Philips Medical Systems (Cleveland) Inc Respiratory Gating System, Catalog Number: NPTA540, Model #4535 674 26701, for the following affected CT/PET scanning device systems : GEMINI TF CT/PET Systems 16 Slice, GEMINI TF CT/PET System 16 Sl Terminated |
JAK | 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 |
| Nov 7, 2007 | Philips Medical Systems (Cleveland) Inc The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC) application. Terminated |
JAK | None listed |
| Sep 26, 2007 | Philips Medical Systems (Cleveland) Inc Brilliance(a) CT 6 slice, Model #4535 670 73191.
Brilliance(a) CT 10 Slice, Model 4535 670 73181.
Brilliance 16 Slice, Model #4535 670 78851.
Brilliance CT 16 Power, Model #4535 670 23331.
Bri Terminated |
KPS | None listed |
| Mar 17, 2007 | Philips Medical Systems (Cleveland) Inc Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1) Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.