510(k) K062298 ยท KPS System, Tomography, Computed, Emission
APOLLO GAMMA CAMERA SYSTEM
| Applicant | Adac Laboratories, Milpitas CA, US |
| Decision | Substantially Equivalent, Aug 23, 2006 |
| Received | Aug 8, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062298
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2024 | Philips North America BrightView, gamma camera system;
Model Nos.:
6-digit format 882480;
12-digit format 453560279781
453560279791
453560279811
453560279801;
4x4 digit format
2170-3000A
2170-3001A
2170-3002A
2170-3003A Open, Classified |
KPS | None listed |
| Jan 5, 2024 | Philips North America BrightView, Gamma Camera System, Product Code 882480. Open, Classified |
KPS | None listed |
| Feb 3, 2018 | Philips Medical Systems (Cleveland) Inc BrightView X, Model #882478
Product Usage:
BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomogra Terminated |
KPS | None listed |
| Feb 3, 2018 | Philips Medical Systems (Cleveland) Inc BrightView XCT Model 882482
Product Usage:
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x Terminated |
KPS | None listed |
| Feb 3, 2018 | Philips Medical Systems (Cleveland) Inc BrightView Model 882480
Product Usage:
BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography 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 |
| May 25, 2016 | Philips Medical Systems (Cleveland) Inc BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging Terminated |
KPS | None listed |
| Dec 17, 2015 | Philips Medical Systems (Cleveland) Inc BrightView are gamma cameras; Designed for single or dual detector nuclear imaging. Terminated |
KPS | None listed |
| Dec 17, 2015 | Philips Medical Systems (Cleveland) Inc BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging. Terminated |
KPS | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc BrightView X (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. 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 |
| Jun 5, 2013 | Philips Medical Systems (Cleveland) Inc BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143
BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging ac Terminated |
KPS | None listed |
| Aug 4, 2011 | Philips Medical Systems BrightView X 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 inte Terminated |
KPS | None listed |
| Jul 22, 2011 | Philips Medical Systems Philips brand BrightView Gamma Camera System,
SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: 2170-3000A;
Product is manufactured and distributed by
Philips Medical Systems (Cleveland), Inc.,
Cleveland, Terminated |
-KP | None listed |
| Jul 22, 2011 | Philips Medical Systems Philips brand BrightView Gamma Camera System,
SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: 4535-602-79781;
Product is manufactured and distributed by
Philips Medical Systems (Cleveland), Inc.,
Clevela Terminated |
KPS | None listed |
| Jul 22, 2011 | Philips Medical Systems Philips brand BrightView Gamma Camera System,
SYST, BRIGHTVIEW-TILT, 3/4", Model Number: 2170-3003A;
Product is manufactured and distributed by
Philips Medical Systems (Cleveland), Inc.,
Cleveland, O Terminated |
KPS | None listed |
| Jul 22, 2011 | Philips Medical Systems Philips brand BrightView Gamma Camera System,
SYST, BRIGHTVIEW-TILT, 3/4", Model Number; 4535-602-79801;
Product is manufactured and distributed by
Philips Medical Systems (Cleveland), Inc.,
Clevelan Terminated |
KPS | None listed |
| Jul 22, 2011 | Philips Medical Systems Philips brand BrightView Gamma Camera System,
SYST, BRIGHTVIEW-TILT, 3/8", Model Number: 2170-3002A;
Product is manufactured and distributed by
Philips Medical Systems (Cleveland), Inc.,
Cleveland, O Terminated |
KPS | None listed |
| Jul 22, 2011 | Philips Medical Systems Philips brand BrightView Gamma Camera System,
SYST, BRIGHTVIEW-TILT, 3/8", Model Number: 4535-602-79811;
Product is manufactured and distributed by
Philips Medical Systems (Cleveland), Inc.,
Clevelan Terminated |
KPS | None listed |
| Sep 16, 2009 | Phillips Nuclear Medicine BrightView Gamma Camera Radius Drive Assembly, manufactured by Philips Medical Systems (Cleveland) Inc., Cleveland, OH, 3/8" tilt, model number 4535604 34811, 3/4"tilt, model number 4535674 34801, Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.