510(k) · Cleared
Recalled · Class II · 2016Autospect
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · KPS System, Tomography, Computed, Emission
Cleared on Mar 31, 2009 as substantially equivalent to K042903 (Adac Laboratories, 2004) after a 42-day review. Its family tree reaches back 2 generations to 1999. 12 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 31, 2009
- Review
- 42 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992317 (1999). 12 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK992317 Autospect Plus with Instill Motion CorrectionAdac Laboratories · 1999
- 1 generation backK042903 AutospecsAdac Laboratories · 2004
- This deviceK090403 AutospectPhilips Medical Systems (Cleveland), Inc. · 2009
- Descendant · cites it directly · 9 of its ownK111336 EBW NM 2.0Philips Medical Systems (Cleveland), Inc. · 2011
- Descendant · 2 generations on · 5 of its ownK162955 Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. · 2016
- Descendant · 3 generations on · 3 of its ownK210831 OnQ NeuroCortechs Labs, Inc. · 2021
- Descendant · 2 generations on · 2 of its ownK151212 Ziostation2Qi Imaging, LLC · 2015
- Descendant · 4 generations on · 1 of its ownK250416 GBrain MRIGalileo Cds, Inc. · 2025
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K111336EBW NM 2.0Philips Medical Systems (Cleveland), Inc. · 2011 · cites it directly9descendants
- K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. · 2016 · 2 generations on5descendants
- K210831OnQ NeuroCortechs Labs, Inc. · 2021 · 3 generations on3descendants
- K151212Ziostation2Qi Imaging, LLC · 2015 · 2 generations on2descendants
- K250416GBrain MRIGalileo Cds, Inc. · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992317 | Autospect Plus with Instill Motion Correction | Adac Laboratories | 1999 | — |
| −1 | K042903 | Autospecs | Adac Laboratories | 2004 | — |
| 0 (this device) | K090403 | Autospect | Philips Medical Systems (Cleveland), Inc. | 2009 | — |
| +1 | K111336 | EBW NM 2.0 | Philips Medical Systems (Cleveland), Inc. | 2011 | — |
| +2 | K162955 | Multi-Modality Tumor Tracking (MMTT) application | Philips Medical Systems Nederland B.V. | 2016 | — |
| +3 | K210831 | OnQ Neuro | Cortechs Labs, Inc. | 2021 | — |
| +2 | K151212 | Ziostation2 | Qi Imaging, LLC | 2015 | — |
| +4 | K250416 | GBrain MRI | Galileo Cds, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K042903 | AutospecsSummary page 2…CONFIDENTIAL E. PREDICATE DEVICE(S) Philips Medical Systems (Cleveland), Inc. AutoSPECT® K042903 (formerly ADAC Laboratories) Digirad Corporation (claim refernice) Cardius-1, -2; -3 and Cardius 1,… | 2004 |
| † | K082368 | Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect Imaging… | 2008 |
What descends from it? (12)
See all 122 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 4, 2016 | Class II | Z-1504-2016 | Software design | The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data… |
| Mar 4, 2016 | Class II | Z-1505-2016 | Software design | The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K111336 (Philips Medical Systems (Cleveland), Inc., 2011) has gone furthest, with 9 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. 2009, this device’s year, is highlighted.
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?
AutoSPECT® produces images, which depict the three-dimensional distribution of radiopharmaceutical tracers in a patient. This software is intended to provide enhancements to gamma camera emission image processing by automating previously manual image processing functions, providing manual and automated motion correction, providing enhanced reconstruction algorithms that include resolution recovery, scatter correction, noise compensation, and attenuation correction via application of a transmission dataset.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090403: Autospect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090403
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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