# K080927: Brightview VCT Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Apr 11, 2008 after 9 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 30 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K952674 (1995). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062298: Apollo Gamma Camera System, Adac Laboratories (2006) Summary page 1.
- K052434: Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera, GE Medical Systems (2005) Summary page 1.

## Most influential descendants
- K083649: Cardius 3 X-Act (2009), 0 descendants of its own

## Recalls of this device
- Dec 15, 2023 · Class I · Z-0930-2024: 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
- Dec 15, 2023 · Class I · Z-0931-2024: 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-0679-2024: 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. 
- Nov 30, 2023 · Class II · Z-0678-2024: 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. 
- Jun 10, 2019 · Class II · Z-2011-2019: An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
- Jun 10, 2019 · Class II · Z-2010-2019: An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
- Jun 10, 2019 · Class II · Z-2009-2019: An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
- 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. 
- Dec 23, 2016 · Class II · Z-1187-2017: The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission.
- Dec 23, 2016 · Class II · Z-1186-2017: The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission.
- May 25, 2016 · Class II · Z-2736-2016: 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
- May 25, 2016 · Class II · Z-2737-2016: 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-1022-2016: 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-1792-2015: 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 12, 2014 · Class II · Z-1011-2015: Unintended detector and gantry movement due to software issues.
- Nov 4, 2014 · Class II · Z-0450-2015: Software issues
- Jun 23, 2014 · Class II · Z-1982-2014: Flat Panel Display (FPD) failed to remain securely locked in the deployed position.
- Dec 19, 2013 · Class II · Z-1074-2014: Three problems were reported to the firm: When positioning for a relative 180 degree non circular acquisition the second (bottom) detector was not positioned correctly causing an inappropriate rotatio
- Oct 23, 2013 · Class II · Z-0203-2015: It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the time of interruption) and did not complete successfully.
- Sep 3, 2013 · Class II · Z-0089-2014: Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position.
- Jun 15, 2011 · Not classified · Z-2948-2011: 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 15, 2011 · Not classified · Z-2949-2011: 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.
- Mar 28, 2011 · Not classified · Z-2155-2011: The current Headholder to support Bright View XCT brain imaging allowed for imaging the brain but doe allow for imaging of the associated shoulder/neck area of the body.
- Mar 28, 2011 · Not classified · Z-2156-2011: The current Headholder to support Bright View XCT brain imaging allowed for imaging the brain but doe allow for imaging of the associated shoulder/neck area of the body.

## Indications for use
BrightView VCT 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. BrightView VCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the VCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView VCT Imaging System should only be used by trained healthcare professionals.

Source page: https://510kreport.com/device/K080927
Methodology: https://510kreport.com/methodology