510(k) · Cleared
ClearedEcat Vision Pet Scanner, Models 3000 & 5000
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 Aug 14, 2002 as substantially equivalent to K962797 (Cti Pet Systems, Inc., 1996) and 2 other predicates after an 89-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Aug 14, 2002
- Review
- 89 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K914350 (1991). 7 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914350 | Icon Computer System | Siemens Gammasonics, Inc. | 1991 | 1 |
| −1 | K981027 | E.Cam Lso 311 Pet/Spect System | Cti Pet Systems, Inc. | 1998 | — |
| 0 (this device) | K021633 | Ecat Vision Pet Scanner, Models 3000 & 5000 | Cti Pet Systems, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 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? (3)
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 |
|---|---|---|---|
| * | K962797 | Ecat Exact & Ecat Exact HR+Summary page 1…Device Manufacturer 5 1O(k) Number ECAT EXACT CTI PET Systems (CPS) K962797 E.CAM LSO 3 11 CTI PET Systems (CPS) IC981027 ECAT PETKT… | 1996 |
| * | K981027 | E.Cam Lso 311 Pet/Spect SystemSummary page 2…nel detectors, LSO crystal detector technology, and coincidence point source transmission scanning design concepts were borrowed from the E.CAM LSO 3 11 PETEPECT system (K981027). The patient handling system (PHS) provided with ECAT Vision scanners is a slightly modified version of the PHS used on the CPS… | 1998 |
| * | K002715 | Ecat Pet Scanner | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
- 4 of the 7 ancestors have a recall of any class.
- 4 other devices also cite its predicate K962797.
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?
CPS ECAT Vision 3000 and ECAT Vision 5000 positron emission tomography (PET) scanners are intended to be utilized by appropriately trained health care professionals to detect the location and distribution of injected positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021633 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021633: Ecat Vision Pet Scanner, Models 3000 & 5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021633
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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