510(k) · Cleared
ClearedQuantitative Gated Spect (QGS), Quantitative Perfusion Spect (QPS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digirad Corp. · KPS System, Tomography, Computed, Emission
Cleared on Jun 15, 2001 as substantially equivalent to K982855 (Digirad Corp., 1998) and 1 other predicate after a 25-day review. Its family tree reaches back 2 generations to 1989. 1 of the 359 devices in its family, counting itself, has a Class I recall. 354 later devices descend from it.
- Decided
- Jun 15, 2001
- Review
- 25 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K885054 (1989). 4 ancestors in all. 354 later devices descend from it, 1 citing it directly. 1 of the 359 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK885054 System Seventy SevenScinticor, Inc. · 1989
- 1 generation backK982855 Digirad 2020TC Spect Imaging SystemDigirad Corp. · 1998
- This deviceK011572 Quantitative Gated Spect (QGS), Quantitative Perfusion Spect (QPS)Digirad Corp. · 2001
- Descendant · cites it directly · 353 of its ownK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- Descendant · 2 generations on · 350 of its ownK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- Descendant · 3 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- Descendant · 4 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 3 generations on · 166 of its ownK062163 MimviewerMimvista Corp. · 2006
Showing 5 of 354 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…9 generations on · 2025
Most influential descendants
Showing 5 of 354 · See all- K052379Mim 3.5 (Circa)Mimvista Corp. · 2005 · cites it directly353descendants
- K060816Mim 4.0 (NeuroMimvista Corp. · 2006 · 2 generations on350descendants
- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 3 generations on287descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 4 generations on200descendants
- K062163MimviewerMimvista Corp. · 2006 · 3 generations on166descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K885054 | System Seventy Seven | Scinticor, Inc. | 1989 | — |
| −1 | K982855 | Digirad 2020TC Spect Imaging System | Digirad Corp. | 1998 | — |
| 0 (this device) | K011572 | Quantitative Gated Spect (QGS), Quantitative Perfusion Spect (QPS) | Digirad Corp. | 2001 | — |
| +1 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| +2 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| +3 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| +4 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +3 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 8 | 0 |
| 2013 | 6 | 0 |
| 2014 | 11 | 0 |
| 2015 | 12 | 0 |
| 2016 | 14 | 0 |
| 2017 | 17 | 0 |
| 2018 | 24 | 0 |
| 2019 | 23 | 0 |
| 2020 | 28 | 0 |
| 2021 | 25 | 0 |
| 2022 | 32 | 0 |
| 2023 | 30 | 0 |
| 2024 | 28 | 0 |
| 2025 | 39 | 1 |
| 2026 | 36 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K982855 | Digirad 2020TC Spect Imaging SystemSummary page 2…020tc SPECT Imaging System. Table 8.1 Predicate devices Existing Digirad QGS/QPS 2020tc SPECT Sponsor: SMV Imaging System America Product Code | 90 KPS 90 KPS 510(k) K982855 | KOO3358 Number Device Description The QGS/QPS programs are independent, standalone software applications developed by Cedars-… | 1998 |
| * | K003358 | QPS (Quantitative Perfusion Spect), QGS (Quantitative Gated Spect) | 2001 |
What descends from it? (354)
See all 3541 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052379 | Mim 3.5 (Circa) | 2005 | 353 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 9.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K052379 (Mimvista Corp., 2005) has gone furthest, with 353 descendants of its own.
- 6 other devices also cite its predicate K982855.
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 Quantitative Gated SPECT (QGS) and Quantitative Perfusion SPECT (QPS) programs are intended for use in the display and quantification of myocardial perfusion and functional parameters from 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/K011572 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011572: Quantitative Gated Spect (QGS), Quantitative Perfusion Spect (QPS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011572
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026