ClearanceBrief
510(k) K062298 ยท KPS System, Tomography, Computed, Emission

APOLLO GAMMA CAMERA SYSTEM

ApplicantAdac Laboratories, Milpitas CA, US
DecisionSubstantially Equivalent, Aug 23, 2006
ReceivedAug 8, 2006
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K062298

DateFirm and productCodeLinked 510(k)
Feb 2, 2024Philips 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
KPSNone listed
Jan 5, 2024Philips North America
BrightView, Gamma Camera System, Product Code 882480.
Open, Classified
KPSNone listed
Feb 3, 2018Philips 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
KPSNone listed
Feb 3, 2018Philips 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
KPSNone listed
Feb 3, 2018Philips 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
KPSNone listed
Apr 6, 2017Philips 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
KPSNone listed
Apr 6, 2017Philips 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
KPSNone listed
Apr 6, 2017Philips 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
KPSNone listed
Apr 6, 2017Philips 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
KPSNone listed
Mar 16, 2017Philips 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
KPSNone listed
Mar 16, 2017Philips 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
KPSNone listed
Mar 16, 2017Philips 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
KPSNone listed
May 25, 2016Philips Medical Systems (Cleveland) Inc
BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging
Terminated
KPSNone listed
Dec 17, 2015Philips Medical Systems (Cleveland) Inc
BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
Terminated
KPSNone listed
Dec 17, 2015Philips Medical Systems (Cleveland) Inc
BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.
Terminated
KPSNone listed
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
BrightView X (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSNone listed
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSNone listed
Dec 1, 2014Philips Medical Systems (Cleveland) Inc
BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
Terminated
KPSNone listed
Jun 5, 2013Philips 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
KPSNone listed
Aug 4, 2011Philips 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
KPSNone listed
Jul 22, 2011Philips 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
-KPNone listed
Jul 22, 2011Philips 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
KPSNone listed
Jul 22, 2011Philips 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
KPSNone listed
Jul 22, 2011Philips 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
KPSNone listed
Jul 22, 2011Philips 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
KPSNone listed
Jul 22, 2011Philips 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
KPSNone listed
Sep 16, 2009Phillips 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
KPSNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.