510(k) · Cleared
ClearedAnyscan-S Spect Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Absolute Imaging Solutions · KPS System, Tomography, Computed, Emission
Cleared on Oct 3, 2013 as substantially equivalent to K072567 (Siemens Medical Solutions USA, Inc., 2007) after a 121-day review. Its family tree reaches back 6 generations to 1995. 1 of the 20 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 3, 2013
- Review
- 121 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K952674 (1995). 19 ancestors in all, the oldest K892358 (1989). No later device cites it as a predicate yet. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 5 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
- 4 generations backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
- 3 generations backK023190 E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002
- 2 generations backK063826 Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007
- 1 generation backK072567 Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · Recalled
- This deviceK131625 Anyscan-S Spect Imaging SystemAbsolute Imaging Solutions · 2013
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…3 generations back · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K952674 | Transact: Attenuation Correction System for the Apex Cardial Gamma Camera | Elscint, Inc. | 1995 | 1 |
| −5 | K980959 | Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma… | Ge Medical Systems F.I. Haifa | 1998 | — |
| −4 | K991841 | Hawkeye Option for Dual-Head Variable Angle Gamma Camera | Ge Medical Systems F.I. Haifa | 1999 | Class I |
| −3 | K023190 | E.Cam Computer / E.Soft Workstation | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −2 | K063826 | Syngo MI Applications 2007A | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −1 | K072567 | Symbia-E, Model 10275879 | Siemens Medical Solutions USA, Inc. | 2007 | 2 |
| 0 (this device) | K131625 | Anyscan-S Spect Imaging System | Absolute Imaging Solutions | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 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.
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? (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 |
|---|---|---|---|
| * | K072567 | Symbia-E, Model 10275879Summary page 1…Camera - SPECT Imaging System Classification Name: Emission Computed Tomography System (ECT) 3.0 Predicate Devices 1. Symbia-E - Siemens [K072567] 4.0 Intended Use / Indications for Use For use to detect or image the distribution of radionuclides in the b… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 12 of the 19 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K072567.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
For use to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging and tomographic imaging.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131625: Anyscan-S Spect Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131625
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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