510(k) · Cleared
ClearedVantage, for Adac Gamma Cameras
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 Apr 26, 1995 after a 275-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Apr 26, 1995
- Review
- 275 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK943596 Vantage, for Adac Gamma CamerasAdac Laboratories · 1995
- Descendant · cites it directly · 5 of its ownK971878 Vantage 2.1 ExspectAdac Laboratories · 1997
- Descendant · 2 generations on · 1 of its ownK992078 Vantage Exspect IIAdac Laboratories · 1999
- Descendant · 3 generations on · 0 of its ownK033735 Vantage Pro Attenuation Correction DeviceAdac Laboratories · 2003
- Descendant · 2 generations on · 0 of its ownK991607 Vantage 2.5Adac Laboratories · 1999
- Descendant · 2 generations on · 0 of its ownK991318 Convergence Nua for Hitachi Spectradigital V250DSP Gamma CamerasHitachi Medical Corp. of America · 1999
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K971878Vantage 2.1 ExspectAdac Laboratories · 1997 · cites it directly5descendants
- K992078Vantage Exspect IIAdac Laboratories · 1999 · 2 generations on1descendant
- K033735Vantage Pro Attenuation Correction DeviceAdac Laboratories · 2003 · 3 generations on0descendants
- K991607Vantage 2.5Adac Laboratories · 1999 · 2 generations on0descendants
- K991318Convergence Nua for Hitachi Spectradigital V250DSP Gamma CamerasHitachi Medical Corp. of America · 1999 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943596 | Vantage, for Adac Gamma Cameras | Adac Laboratories | 1995 | — |
| +1 | K971878 | Vantage 2.1 Exspect | Adac Laboratories | 1997 | — |
| +2 | K992078 | Vantage Exspect II | Adac Laboratories | 1999 | — |
| +3 | K033735 | Vantage Pro Attenuation Correction Device | Adac Laboratories | 2003 | — |
| +2 | K991607 | Vantage 2.5 | Adac Laboratories | 1999 | — |
| +2 | K991318 | Convergence Nua for Hitachi Spectradigital V250DSP Gamma Cameras | Hitachi Medical Corp. of America | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPS? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K971878 (Adac Laboratories, 1997) has gone furthest, with 5 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.
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 | — |
https://510kreport.com/device/K943596 · printed Nov 4, 2026
Cite this page
510(k) Report. “K943596: Vantage, for Adac Gamma Cameras.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K943596
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026