510(k) · Cleared
Recalled · 2006Ecat Pet Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cti Pet Systems, Inc. · KPS System, Tomography, Computed, Emission
Cleared on Dec 13, 2000 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 13, 2000
- Review
- 57 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 2
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK003241 Ecat Pet ScannerCti Pet Systems, Inc. · 2000
- Descendant · cites it directly · 2 of its ownK032063 Pem 2400 Pet ScannerPem Technologies · 2003 · Recalled
- Descendant · 2 generations on · 1 of its ownK090553 Naviscan Pemflex Solo II High Resolution Pet ScannerNaviscan, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK214062 Radialis PET CameraRadialis, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK042428 SCEPTREP3 Pet/CTHitachi Medical Systems America, Inc. · 2004 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K032063Pem 2400 Pet ScannerPem Technologies · 2003 · cites it directly2descendants
- K090553Naviscan Pemflex Solo II High Resolution Pet ScannerNaviscan, Inc. · 2009 · 2 generations on1descendant
- K214062Radialis PET CameraRadialis, Inc. · 2022 · 3 generations on0descendants
- K042428SCEPTREP3 Pet/CTHitachi Medical Systems America, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003241 | Ecat Pet Scanner | Cti Pet Systems, Inc. | 2000 | — |
| +1 | K032063 | Pem 2400 Pet Scanner | Pem Technologies | 2003 | 2 |
| +2 | K090553 | Naviscan Pemflex Solo II High Resolution Pet Scanner | Naviscan, Inc. | 2009 | — |
| +3 | K214062 | Radialis PET Camera | Radialis, Inc. | 2022 | — |
| +1 | K042428 | SCEPTREP3 Pet/CT | Hitachi Medical Systems America, Inc. | 2004 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 28, 2006 | Not classified | Z-0712-06 | Other | There is a potential for inaccurate, elevated SUVs (standardized uptake values). On follow-up scans, the elevated SUV could be misinterpreted, and inappropriately impact a patient's treatment plan. |
| Apr 5, 2005 | Not classified | Z-0819-05 | Other | Failure to properly secure the Mobile Bed Supports during transit could cause the support screws on the Patient Handling System to become loose and possibly break due to increased vibration during transit. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K032063 (Pem Technologies, 2003) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K003241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003241: Ecat Pet Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003241
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026