Atlas FDA

APOLLO GAMMA CAMERA SYSTEM

FDA 510(k) clearance K062298 · decided 2006-08-23

Clearance details

K-number
K062298
Device name
APOLLO GAMMA CAMERA SYSTEM
Applicant
Adac Laboratories
Decision
Substantially Equivalent
Date received
2006-08-08
Decision date
2006-08-23
Days to decision
15 days
Clearance type
Traditional
Product code
KPS
Device class
2
Regulation number
892.1200
Medical specialty
Radiology
Advisory committee
Radiology
Location
Milpitas, CA, US
Third-party review
Yes
Expedited review
No

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Recalls involving this device

RecordFirmDate
BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560 recall (Z-0929-2024)Philips North America2024-02-02
BrightView, Gamma Camera System, Product Code 882480. recall (Z-0677-2024)Philips North America2024-01-05
BrightView X, Model #882478 Product Usage: BrightView and BrightView X are gamma cameras d recall (Z-0510-2018)Philips Medical Systems (Cleveland) Inc2018-02-03
BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma camera for Single Pho recall (Z-0511-2018)Philips Medical Systems (Cleveland) Inc2018-02-03
BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras desig recall (Z-0512-2018)Philips Medical Systems (Cleveland) Inc2018-02-03
BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designe recall (Z-1750-2017)Philips Medical Systems (Cleveland) Inc2017-04-06
BrightView XCT model number 882482 BrightView and BrightView X are gamma cameras designed recall (Z-1751-2017)Philips Medical Systems (Cleveland) Inc2017-04-06
BrightView X 3/4 model number 882479 BrightView and BrightView X are gamma cameras designe recall (Z-1752-2017)Philips Medical Systems (Cleveland) Inc2017-04-06
BrightView X 3/8 model number 882478 BrightView and BrightView X are gamma cameras designe recall (Z-1753-2017)Philips Medical Systems (Cleveland) Inc2017-04-06
882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual det recall (Z-1479-2017)Philips Medical Systems (Cleveland) Inc2017-03-16
882480: BrightView designed for single or dual detector nuclear imaging accommodating a ra recall (Z-1480-2017)Philips Medical Systems (Cleveland) Inc2017-03-16
882478: BrightView X designed for single or dual detector nuclear imaging accommodating a recall (Z-1481-2017)Philips Medical Systems (Cleveland) Inc2017-03-16
BrightView X (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X- recall (Z-1790-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomograph recall (Z-1791-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product c recall (Z-0450-2015)Philips Medical Systems (Cleveland) Inc2014-12-01
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, C recall (Z-1481-2013)Philips Medical Systems (Cleveland) Inc2013-06-05
BrightView X Gamma Camera, 3/8". Philips Medical Systems, Inc. Intended to produce images recall (Z-2947-2011)Philips Medical Systems2011-08-04
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: recall (Z-2867-2011)Philips Medical Systems2011-07-22
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: recall (Z-2868-2011)Philips Medical Systems2011-07-22
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/4", Model Number: 2 recall (Z-2869-2011)Philips Medical Systems2011-07-22
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/4", Model Number; 4 recall (Z-2870-2011)Philips Medical Systems2011-07-22
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/8", Model Number: 2 recall (Z-2871-2011)Philips Medical Systems2011-07-22
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/8", Model Number: 4 recall (Z-2872-2011)Philips Medical Systems2011-07-22
BrightView Gamma Camera Radius Drive Assembly, manufactured by Philips Medical Systems (Cl recall (Z-1892-2009)Phillips Nuclear Medicine2009-09-16