510(k) · Cleared
ClearedAutoquant Plus
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 Feb 25, 2004 as substantially equivalent to K980715 (Adac Laboratories, 1998) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it.
- Decided
- Feb 25, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003264 (2000). 3 ancestors in all, the oldest K980715 (1998). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK003264 QPS/BPGS/Moco Processing Applications for Entegra WorkstationGe Medical Systems F.I. Haifa · 2000
- 1 generation backK022428 Quantitative Blood Pool Spect (QBS)Adac Laboratories · 2002
- This deviceK040326 Autoquant PlusAdac Laboratories · 2004
- Descendant · cites it directly · 1 of its ownK060020 Autoquant PlusAdac Laboratories · 2006
- Descendant · cites it directly · 0 of its ownK213731 EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile WorkflowsEver Fortune.Ai, Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK100714 CSMC Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01Cedars-Sinai Medical Center · 2011
Most influential descendants
Showing 3 of 3 · See all- K060020Autoquant PlusAdac Laboratories · 2006 · cites it directly1descendant
- K213731EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile WorkflowsEver Fortune.Ai, Co., Ltd. · 2022 · cites it directly0descendants
- K100714CSMC Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01Cedars-Sinai Medical Center · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003264 | QPS/BPGS/Moco Processing Applications for Entegra Workstation | Ge Medical Systems F.I. Haifa | 2000 | — |
| −1 | K022428 | Quantitative Blood Pool Spect (QBS) | Adac Laboratories | 2002 | — |
| 0 (this device) | K040326 | Autoquant Plus | Adac Laboratories | 2004 | — |
| +1 | K060020 | Autoquant Plus | Adac Laboratories | 2006 | — |
| +1 | K213731 | EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows | Ever Fortune.Ai, Co., Ltd. | 2022 | — |
| +2 | K100714 | CSMC Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01 | Cedars-Sinai Medical Center | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2022 | 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 18.7 · 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 |
|---|---|---|---|
| * | K980715 | Autoquant Quantitative Perfusion Spect (QPS) & Quantitative Gated Spect (QGS)Summary page 1…Manufacturer Product Name 510(k) No. ADAC Laboratories AutoQUANT® K980715 ADAC Laboratories Quantitative Blood Pool SPECT (QBS) K022428 E. Intended Use: AutoQUANT®… | 1998 |
| * | K022428 | Quantitative Blood Pool Spect (QBS)Summary page 1…ADAC Laboratories AutoQUANT® K980715 ADAC Laboratories Quantitative Blood Pool SPECT (QBS) K022428 E. Intended Use: AutoQUANT® Plus applications are intended to enable an automated display, review, and quantification… | 2002 |
What descends from it? (3)
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?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K060020 (Adac Laboratories, 2006) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K980715.
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?
AutoQUANT® Plus applications are intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets.
AutoQUANT® Plus may be used in multiple settings including the hospital, clinic, doctors office, or remotely via dial up. The results provided should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040326 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040326: Autoquant Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040326
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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