510(k) · Cleared
Recalled · Class I · 2023Brightview VCT Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · KPS System, Tomography, Computed, Emission
Cleared on Apr 11, 2008 as substantially equivalent to K062298 (Adac Laboratories, 2006) and 1 other predicate after a 9-day review. Its family tree reaches back 4 generations to 1995. 6 of the 9 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 30 times, including 2 Class I recalls.
- Decided
- Apr 11, 2008
- Review
- 9 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 30 (2 Class I)
- Predicates
- 2
Its longest line of descent runs back 4 generations to K952674 (1995). 7 ancestors in all. 1 later device descends from it, 1 citing it directly. 6 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 3 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
- 2 generations backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
- 1 generation backK052434 Hawkeye 4 Option for Dual-Head Variable Angle Gamma CameraGE Medical Systems · 2005 · Recalled (Class I)
- This deviceK080927 Brightview VCT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2008
- Descendant · cites it directly · 0 of its ownK083649 Cardius 3 X-ActDigirad Corp. · 2009
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K083649Cardius 3 X-ActDigirad Corp. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K952674 | Transact: Attenuation Correction System for the Apex Cardial Gamma Camera | Elscint, Inc. | 1995 | 1 |
| −3 | K980959 | Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma… | Ge Medical Systems F.I. Haifa | 1998 | — |
| −2 | K991841 | Hawkeye Option for Dual-Head Variable Angle Gamma Camera | Ge Medical Systems F.I. Haifa | 1999 | Class I |
| −1 | K052434 | Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera | GE Medical Systems | 2005 | Class I |
| 0 (this device) | K080927 | Brightview VCT Imaging System | Philips Medical Systems (Cleveland), Inc. | 2008 | — |
| +1 | K083649 | Cardius 3 X-Act | Digirad Corp. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 1 |
| 2003 | 1 | 1 |
| 2006 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
6 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062298 | Apollo Gamma Camera SystemSummary page 1…duct Code: 90 KPS C. Date prepared: March 19, 2008 D. Predicate Devices: BrightViewTM Gamma Camera System (K062298) GE 4 Option for Dual-Head Variable Angle Gamma… | 2006 |
| * | K052434 | Hawkeye 4 Option for Dual-Head Variable Angle Gamma CameraSummary page 1…TM Gamma Camera System (K062298) GE 4 Option for Dual-Head Variable Angle Gamma Camera (K052434) E. Intended Use: BrightViewTm VCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083649 | Cardius 3 X-Act | 2009 | 0 |
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2023 | Class I | Z-0930-2024 | Component design/selection | 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 patient's lower limbs, as well as an… |
| Dec 15, 2023 | Class I | Z-0931-2024 | Component design/selection | 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 patient's lower limbs, as well as an… |
| Nov 30, 2023 | Class II | Z-0679-2024 | Device Design | 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. Risk to patients may include fracture… |
| Nov 30, 2023 | Class II | Z-0678-2024 | Device Design | 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. Risk to patients may include fracture… |
| Jun 10, 2019 | Class II | Z-2011-2019 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Software design | 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. JETStream freezes during gated planar… |
| Jan 31, 2017 | Class II | Z-1479-2017 | Software design | 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. JETStream freezes during gated planar… |
| Jan 31, 2017 | Class II | Z-1480-2017 | Software design | 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. JETStream freezes during gated planar… |
| Dec 23, 2016 | Class II | Z-1187-2017 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Software design | 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 defect in the workflow setup script. |
| May 25, 2016 | Class II | Z-2737-2016 | Software design | 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 defect in the workflow setup script. |
| Dec 17, 2015 | Class II | Z-1022-2016 | Software design | 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 come in contact with the bottom edge of… |
| Mar 6, 2015 | Class II | Z-1792-2015 | Nonconforming Material/Component | 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, overheating and/or emission of fumes. |
| Nov 12, 2014 | Class II | Z-1011-2015 | Software design | Unintended detector and gantry movement due to software issues. |
| Nov 4, 2014 | Class II | Z-0450-2015 | Software design | Software issues |
| Jun 23, 2014 | Class II | Z-1982-2014 | Device Design | Flat Panel Display (FPD) failed to remain securely locked in the deployed position. |
| Dec 19, 2013 | Class II | Z-1074-2014 | Software design | 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 rotation orbit calculation. When the… |
| Oct 23, 2013 | Class II | Z-0203-2015 | Radiation Control for Health and Safety Act | 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 | Device Design | 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 | Software design | 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 | Software design | 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 | Device Design | 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 | Device Design | 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. |
The 5 latest of 30 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K062298Apollo Gamma Camera SystemAdac Laboratories · 2006 · Direct predicate · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
- K052434Hawkeye 4 Option for Dual-Head Variable Angle Gamma CameraGE Medical Systems · 2005 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K033254Forte Gamma Camera SystemAdac Laboratories · 2003 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 13 Class I recalls
- K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K982911FORTEAdac Laboratories · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 6 of the 7 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K083649 (Digirad Corp., 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080927 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080927: Brightview VCT Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080927
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026