# K062298: Apollo Gamma Camera System

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Aug 23, 2006 after 15 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 27 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K982911 (1998). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
4 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033254: Forte Gamma Camera System, Adac Laboratories (2003) Summary page 1.

## Most influential descendants
- K080927: Brightview VCT Imaging System (2008), 1 descendant of its own
- K083649: Cardius 3 X-Act (2009), 0 descendants of its own

## Recalls of this device
- Dec 15, 2023 · Class I · Z-0929-2024: Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patien
- Nov 30, 2023 · Class II · Z-0677-2024: While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. 
- Dec 15, 2017 · Class II · Z-0510-2018: During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator m
- Dec 15, 2017 · Class II · Z-0512-2018: During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator m
- Dec 15, 2017 · Class II · Z-0511-2018: During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator m
- Feb 24, 2017 · Class II · Z-1752-2017: The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
- Feb 24, 2017 · Class III · Z-1753-2017: The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
- Feb 24, 2017 · Class II · Z-1750-2017: The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
- Feb 24, 2017 · Class II · Z-1751-2017: The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
- Jan 31, 2017 · Class II · Z-1481-2017: Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. 
- Jan 31, 2017 · Class II · Z-1479-2017: Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. 
- Jan 31, 2017 · Class II · Z-1480-2017: Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. 
- May 25, 2016 · Class II · Z-2735-2016: The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defec
- Dec 17, 2015 · Class II · Z-1020-2016: The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may c
- Dec 17, 2015 · Class II · Z-1021-2016: The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may c
- Mar 6, 2015 · Class II · Z-1790-2015: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overh
- Mar 6, 2015 · Class II · Z-1791-2015: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overh
- Nov 4, 2014 · Class II · Z-0450-2015: Software issues
- Apr 25, 2013 · Class II · Z-1481-2013: Philips has received one report from the field that there was an unexpected motion of the detector due to a failure of the mechanical assembly.
- Jun 15, 2011 · Not classified · Z-2947-2011: Non-conformances with BrightView X/XCT systems running version 2.0.1 including data transfer, XCT acquisition, Pixel Mask for image reconstruction and table moving incorrectly.
- Jun 3, 2011 · Not classified · Z-2867-2011: The gap between the two parts of the table may permit pinches to occur on either patients skin or other body parts; it has the potential for serious injury if a patients finger is caught between the p
- Jun 3, 2011 · Not classified · Z-2870-2011: The gap between the two parts of the table may permit pinches to occur on either patient's skin or other body parts; it has the potential for serious injury if a patient's finger is caught between the
- Jun 3, 2011 · Not classified · Z-2868-2011: The gap between the two parts of the table may permit pinches to occur on either patient's skin or other body parts; it has the potential for serious injury if a patient's finger is caught between the
- Jun 3, 2011 · Not classified · Z-2869-2011: The gap between the two parts of the table may permit pinches to occur on either patient's skin or other body parts; it has the potential for serious injury if a patient's finger is caught between the
- Jun 3, 2011 · Not classified · Z-2872-2011: The gap between the two parts of the table may permit pinches to occur on either patient's skin or other body parts; it has the potential for serious injury if a patient's finger is caught between the
- Jun 3, 2011 · Not classified · Z-2871-2011: The gap between the two parts of the table may permit pinches to occur on either patient's skin or other body parts; it has the potential for serious injury if a patient's finger is caught between the
- Jul 2, 2009 · Not classified · Z-1892-2009: Unexpected movement-- if the drive assembly is severely compromised, the detector may slide to its hardware limit.

## Indications for use
The Apollo Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.

Source page: https://510kreport.com/device/K062298
Methodology: https://510kreport.com/methodology