510(k) · Cleared
ClearedAutospect Plus with Instill Motion Correction
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 Oct 1, 1999 after an 84-day review. The FDA summary names its predicate without a number. 22 later devices descend from it.
- Decided
- Oct 1, 1999
- Review
- 84 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 4 citing it directly.
- This deviceK992317 Autospect Plus with Instill Motion CorrectionAdac Laboratories · 1999
- Descendant · cites it directly · 13 of its ownK042903 AutospecsAdac Laboratories · 2004
- Descendant · 2 generations on · 12 of its ownK090403 AutospectPhilips Medical Systems (Cleveland), Inc. · 2009 · Recalled
- Descendant · 3 generations on · 9 of its ownK111336 EBW NM 2.0Philips Medical Systems (Cleveland), Inc. · 2011
- Descendant · 4 generations on · 5 of its ownK162955 Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. · 2016
- Descendant · cites it directly · 5 of its ownK071503 System, Tomography, Computed EmissionSyntermed, Inc. · 2007
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K042903AutospecsAdac Laboratories · 2004 · cites it directly13descendants
- K090403AutospectPhilips Medical Systems (Cleveland), Inc. · 2009 · 2 generations on12descendants
- K111336EBW NM 2.0Philips Medical Systems (Cleveland), Inc. · 2011 · 3 generations on9descendants
- K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. · 2016 · 4 generations on5descendants
- K071503System, Tomography, Computed EmissionSyntermed, Inc. · 2007 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992317 | Autospect Plus with Instill Motion Correction | Adac Laboratories | 1999 | — |
| +1 | K042903 | Autospecs | Adac Laboratories | 2004 | — |
| +2 | K090403 | Autospect | Philips Medical Systems (Cleveland), Inc. | 2009 | 2 |
| +3 | K111336 | EBW NM 2.0 | Philips Medical Systems (Cleveland), Inc. | 2011 | — |
| +4 | K162955 | Multi-Modality Tumor Tracking (MMTT) application | Philips Medical Systems Nederland B.V. | 2016 | — |
| +1 | K071503 | System, Tomography, Computed Emission | Syntermed, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | — | SMV Statis™ Named without a submission number | |
| * | — | SMV MyoSPECT with ReOrient Express Named without a submission number |
What descends from it? (22)
See all 224 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, K042903 (Adac Laboratories, 2004) has gone furthest, with 13 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 AutoSPECT Plus with InStill Motion Correction option to the ADAC Gamma Camera Systems produces images which depict anatomical density of the patient. This system is intended to provide enhancements of gamma camera emission images by automating previously manual image processing functions and providing manual and automated motion correction.
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/K992317 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992317: Autospect Plus with Instill Motion Correction.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992317
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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