510(k) · Cleared
ClearedVcar Option to Vision FX-80 Gamma Camera and Power Station
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smv America · KPS System, Tomography, Computed, Emission
Cleared on Mar 11, 1997 as substantially equivalent to K930428 (Ugm Medical Systems, Inc., 1993) and 1 other predicate after a 203-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Mar 11, 1997
- Review
- 203 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930428 (1993). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK930428 Penn-Pet ScannerUgm Medical Systems, Inc. · 1993
- This deviceK963273 Vcar Option to Vision FX-80 Gamma Camera and Power StationSmv America · 1997
- Descendant · cites it directly · 0 of its ownK972686 Vcar Option to the DST and DST-XL Gamma Cameras and Vision…Smv America · 1997
Most influential descendants
Showing 1 of 1 · See all- K972686Vcar Option to the DST and DST-XL Gamma Cameras and Vision Powerstation ComputerSmv America · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930428 | Penn-Pet Scanner | Ugm Medical Systems, Inc. | 1993 | — |
| 0 (this device) | K963273 | Vcar Option to Vision FX-80 Gamma Camera and Power Station | Smv America | 1997 | — |
| +1 | K972686 | Vcar Option to the DST and DST-XL Gamma Cameras and Vision Powerstation Computer | Smv America | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 |
|---|---|---|---|
| * | K930428 | Penn-Pet ScannerSummary page 1…ng Gamma Camera System VCAR option to VISION FX-80 Gamma Camera and Power Station SPONSOR PRODUCT | Preamendment Status or 510(k) Number UGM Medical Systems, Penn-PET K930428 Inc. (marketed as GE Quest 300) ADAC Laboratories MCD option to VERTEX Epic K952684 N System SMV America Appendic… | 1993 |
| * | K952684 | Vertex Epic MCDSummary page 1…SPONSOR PRODUCT | Preamendment Status or 510(k) Number UGM Medical Systems, Penn-PET K930428 Inc. (marketed as GE Quest 300) ADAC Laboratories MCD option to VERTEX Epic K952684 N System SMV America Appendices VCAR Option 510(k) Page 46 of 48 Device Description Summary: The VCAR option to… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972686 | Vcar Option to the DST and DST-XL Gamma Cameras and Vision Powerstation Computer | 1997 | 0 |
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?
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 VCAR option to the VISION FX-80 Gamma Camera and Power Station produces images which depict the anatomical distribution of radioisotopes within the human body, for interpretation by medical clinicians. The system is intended for whole body nuclear imaging.
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/K963273 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963273: Vcar Option to Vision FX-80 Gamma Camera and Power Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963273
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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