510(k) · Cleared
Recalled · Class I · 2023Apollo Gamma Camera System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adac Laboratories · KPS System, Tomography, Computed, Emission
Cleared on Aug 23, 2006 as substantially equivalent to K033254 (Adac Laboratories, 2003) after a 15-day review. Its family tree reaches back 2 generations to 1998. 4 of the 5 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 27 times, including a Class I recall.
- Decided
- Aug 23, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 27 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K982911 (1998). 2 later devices descend from it, 1 citing it directly. 4 of the 5 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK982911 FORTEAdac Laboratories · 1998 · Recalled (Class I)
- 1 generation backK033254 Forte Gamma Camera SystemAdac Laboratories · 2003 · Recalled (Class I)
- This deviceK062298 Apollo Gamma Camera SystemAdac Laboratories · 2006
- Descendant · cites it directly · 1 of its ownK080927 Brightview VCT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2008 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK083649 Cardius 3 X-ActDigirad Corp. · 2009
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982911 | FORTE | Adac Laboratories | 1998 | Class I |
| −1 | K033254 | Forte Gamma Camera System | Adac Laboratories | 2003 | Class I |
| 0 (this device) | K062298 | Apollo Gamma Camera System | Adac Laboratories | 2006 | — |
| +1 | K080927 | Brightview VCT Imaging System | Philips Medical Systems (Cleveland), Inc. | 2008 | Class I |
| +2 | K083649 | Cardius 3 X-Act | Digirad Corp. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
| 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.
4 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? (1)
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 |
|---|---|---|---|
| * | K033254 | Forte Gamma Camera SystemSummary page 1…ct Code: 90 KPS C. Date prepared: July 21, 2006 D. Predicate Device: ForteTm Gamma Camera System (K033254) E. Intended Use: The Apollo Gamma Camera System is intended to produce images depicting the anatomical distributions of… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080927 | Brightview VCT Imaging System Class I | 2008 | 1 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2023 | Class I | Z-0929-2024 | 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-0677-2024 | 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… |
| Dec 15, 2017 | Class II | Z-0510-2018 | Under Investigation by firm | 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 may be partially supported by the cart… |
| Dec 15, 2017 | Class II | Z-0512-2018 | Under Investigation by firm | 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 may be partially supported by the cart… |
| Dec 15, 2017 | Class II | Z-0511-2018 | Under Investigation by firm | 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 may be partially supported by the cart… |
| 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… |
| May 25, 2016 | Class II | Z-2735-2016 | 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-1020-2016 | 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… |
| Dec 17, 2015 | Class II | Z-1021-2016 | 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-1790-2015 | 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. |
| Mar 6, 2015 | Class II | Z-1791-2015 | 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 4, 2014 | Class II | Z-0450-2015 | Software design | Software issues |
| Apr 25, 2013 | Class II | Z-1481-2013 | Other | 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 | 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 3, 2011 | Not classified | Z-2867-2011 | Device Design | 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 pallet and patient table resulting in… |
| Jun 3, 2011 | Not classified | Z-2870-2011 | Device Design | 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 pallet and patient table resulting in… |
| Jun 3, 2011 | Not classified | Z-2868-2011 | Device Design | 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 pallet and patient table resulting in… |
| Jun 3, 2011 | Not classified | Z-2869-2011 | Device Design | 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 pallet and patient table resulting in… |
| Jun 3, 2011 | Not classified | Z-2872-2011 | Device Design | 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 pallet and patient table resulting in… |
| Jun 3, 2011 | Not classified | Z-2871-2011 | Device Design | 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 pallet and patient table resulting in… |
| Jul 2, 2009 | Not classified | Z-1892-2009 | Process control | Unexpected movement-- if the drive assembly is severely compromised, the detector may slide to its hardware limit. |
The 5 latest of 27 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.
- K033254Forte Gamma Camera SystemAdac Laboratories · 2003 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
- K982911FORTEAdac Laboratories · 1998 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K080927Brightview VCT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 4.9 years on median.
- 2 of the 2 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K080927 (Philips Medical Systems (Cleveland), Inc., 2008) has gone furthest, with 1 descendant 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.
FDA decisions per year · KPS
12in 2025
2007high 17 (2008) · low 3 (2010)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
2007high 112 (2015) · low 25 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
2007high 34 (2011) · low 4 (2010)2026
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
2007high 240 (2013) · low 10 (2016)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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062298 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062298: Apollo Gamma Camera System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062298
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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