510(k) · Cleared
ClearedAutoquant Quantitative Perfusion Spect (QPS) & Quantitative Gated Spect (QGS)
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 May 6, 1998 after a 71-day review. The FDA summary names its predicate without a number. 15 later devices descend from it.
- Decided
- May 6, 1998
- Review
- 71 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 3 citing it directly.
- This deviceK980715 Autoquant Quantitative Perfusion Spect (QPS) & Quantitative Gated…Adac Laboratories · 1998
- Descendant · cites it directly · 10 of its ownK072468 Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2007 · Recalled
- Descendant · cites it directly · 9 of its ownK110507 Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011
- Descendant · 2 generations on · 5 of its ownK161740 D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. · 2016
- Descendant · 3 generations on · 4 of its ownK180514 Veriton NMSpectrum Dynamics Medical, Ltd. · 2018
- Descendant · 4 generations on · 3 of its ownK182484 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2018
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K072468Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2007 · cites it directly10descendants
- K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011 · cites it directly9descendants
- K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. · 2016 · 2 generations on5descendants
- K180514Veriton NMSpectrum Dynamics Medical, Ltd. · 2018 · 3 generations on4descendants
- K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2018 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980715 | Autoquant Quantitative Perfusion Spect (QPS) & Quantitative Gated Spect (QGS) | Adac Laboratories | 1998 | — |
| +1 | K072468 | Modification to D-Spect Cardiac Scanner System | Spectrum Dynamics, Ltd. | 2007 | 1 |
| +1 | K110507 | Cardiac Scanner and Processing System | Spectrum Dynamics (Israel), Ltd. | 2011 | — |
| +2 | K161740 | D-SPECT Scanner, D-SPECT L Scanner | Spectrum Dynamics Medical, Ltd. | 2016 | — |
| +3 | K180514 | Veriton NM | Spectrum Dynamics Medical, Ltd. | 2018 | — |
| +4 | K182484 | VERITON CT whole body SPECT/CT system | Spectrum Dynamics Medical, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
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? (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 |
|---|---|---|---|
| * | — | Adac Cequal® Named without a submission number | |
| * | — | Sopha Sophy NXT Named without a submission number |
What descends from it? (15)
See all 153 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, K072468 (Spectrum Dynamics, Ltd., 2007) has gone furthest, with 10 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 | — |
What is it indicated for?
The AutoQUANT, Quantitative Perfusion SPECT (QPS), and Quantitative Gated SPECT (QGS) applications are intended to enable a fully automated review and quantification of Cardiac SPECT data.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980715 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980715: Autoquant Quantitative Perfusion Spect (QPS) & Quantitative Gated Spect (QGS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980715
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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