510(k) K080927 ยท KPS System, Tomography, Computed, Emission
BRIGHTVIEW VCT IMAGING SYSTEM
| Applicant | Philips Medical Systems (Cleveland), Inc., Milpitas CA, US |
| Decision | Substantially Equivalent, Apr 11, 2008 |
| Received | Apr 2, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080927
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2024 | Philips North America BrightView X, gamma camera for SPECT;
Model Nos.:
6-digit format 882478;
12-digit format 453560824741
453560829261; Open, Classified |
KPS | None listed |
| Feb 2, 2024 | Philips North America BrightView XCT, gamma camera for SPECT;
Model Nos.:
6-digit format 882482;
12-digit format 453560462131
453560749161 Open, Classified |
KPS | None listed |
| Jan 5, 2024 | Philips North America BrightView X, Gamma Camera, Product Code 882478 Open, Classified |
KPS | None listed |
| Jan 5, 2024 | Philips North America BrightView XCT, Gamma Camera, Product Code 882482 Open, Classified |
KPS | None listed |
| Jun 10, 2019 | Philips Medical Systems (Cleveland) Inc BrightView SPECT, Model Number 882480 Terminated |
KPS | None listed |
| Jun 10, 2019 | Philips Medical Systems (Cleveland) Inc BrightView X , Model Number 882478 Terminated |
KPS | None listed |
| Jun 10, 2019 | Philips Medical Systems (Cleveland) Inc BrightView XCT , Model Number 882482 Terminated |
KPS | None listed |
| Apr 6, 2017 | Philips Medical Systems (Cleveland) Inc BrightView SPECT model number 882480
BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT Terminated |
KPS | None listed |
| Apr 6, 2017 | Philips Medical Systems (Cleveland) Inc BrightView XCT model number 882482
BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) Terminated |
KPS | None listed |
| Apr 6, 2017 | Philips Medical Systems (Cleveland) Inc BrightView X 3/4 model number 882479
BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT Terminated |
KPS | None listed |
| Apr 6, 2017 | Philips Medical Systems (Cleveland) Inc BrightView X 3/8 model number 882478
BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT Terminated |
KPS | None listed |
| Mar 16, 2017 | Philips Medical Systems (Cleveland) Inc 882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar stati Terminated |
KPS | None listed |
| Mar 16, 2017 | Philips Medical Systems (Cleveland) Inc 882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular- Terminated |
KPS | None listed |
| Mar 16, 2017 | Philips Medical Systems (Cleveland) Inc 882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circula Terminated |
KPS | None listed |
| Dec 23, 2016 | Philips Medical Systems (Cleveland) Inc BrightView XCT Terminated |
KPS | None listed |
| Dec 23, 2016 | Philips Medical Systems (Cleveland) Inc BrightView X upgraded to XCT 882454 Terminated |
KPS | None listed |
| May 25, 2016 | Philips Medical Systems (Cleveland) Inc BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT) Terminated |
KPS | None listed |
| May 25, 2016 | Philips Medical Systems (Cleveland) Inc BrightView XCT Upgrade Model 882454 Terminated |
KPS | None listed |
| Dec 17, 2015 | Philips Medical Systems (Cleveland) Inc BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography. Terminated |
KPS | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | None listed |
| Jan 26, 2015 | Philips Medical Systems (Cleveland) Inc BrightView model number: 882478
BrightView X model number: 882480
BrightView XCT model number: 882482 and 882454
Medical Device for imaging Terminated |
KPS | None listed |
| Dec 12, 2014 | Philips Medical Systems, Inc. BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. Terminated |
KPS | None listed |
| Dec 1, 2014 | Philips Medical Systems (Cleveland) Inc BrightView product code: 882478
BrightView X product code: 882480
BrightView XCT product code: 882482 and 882454 Terminated |
KPS | None listed |
| Jul 2, 2014 | Philips Medical Systems (Cleveland) Inc BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454. Gamma camera for Single Photon Emission Computed Tomography (SPECT) Medical De Terminated |
KPS | None listed |
| Feb 24, 2014 | Philips Medical Systems (Cleveland) Inc Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH.
Gamma cameras designed for single or dual d Terminated |
KPS | None listed |
| Oct 28, 2013 | Philips Medical Systems (Cleveland) Inc BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box.
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and i Terminated |
KPS | None listed |
| Aug 4, 2011 | Philips Medical Systems BrightView XCT Gamma Camera, 3/8".
Philips Medical Systems, Inc.
Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for in Terminated |
KPS | None listed |
| Aug 4, 2011 | Philips Medical Systems BrightView XCT Gamma Camera, 3/4".
Philips Medical Systems, Inc.
Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for in Terminated |
KPS | None listed |
| May 9, 2011 | Philips Medical Systems Brightview XCT, 3/8"
Philips Medical Systems
Brightview XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrated with an attenuation device consisting of flat pane Terminated |
KPS | None listed |
| May 9, 2011 | Philips Medical Systems Brightview XCT, 3/4"
Philips Medical Systems
Brightview XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrated with an attenuation device consisting of flat pane Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.