510(k) · Cleared
ClearedPet Vcar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems SCS · KPS System, Tomography, Computed, Emission
Cleared on Jul 27, 2021 as substantially equivalent to K063324 (GE Healthcare, 2007) after a 92-day review. Its family tree reaches back 7 generations to 1991. 1 later device descends from it.
- Decided
- Jul 27, 2021
- Review
- 92 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K913770 (1991). 15 ancestors in all, the oldest K871859 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 5 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 4 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 3 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 2 generations backK042694 Advanced Lung Analysis IIGE Medical Systems · 2004
- 1 generation backK063324 Pet VcarGE Healthcare · 2007 · Recalled
- This deviceK211247 Pet VcarGE Medical Systems SCS · 2021
- Descendant · cites it directly · 0 of its ownK251883 MIM – LesionID ProMim Software, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251883MIM – LesionID ProMim Software, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −6 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −5 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −4 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −3 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −2 | K042694 | Advanced Lung Analysis II | GE Medical Systems | 2004 | — |
| −1 | K063324 | Pet Vcar | GE Healthcare | 2007 | 1 |
| 0 (this device) | K211247 | Pet Vcar | GE Medical Systems SCS | 2021 | — |
| +1 | K251883 | MIM – LesionID Pro | Mim Software, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (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 |
|---|---|---|---|
| * | K063324 | Pet VcarSummary page 4…Class II Predicate Device: Device Name: PET VCAR Manufacturer: GE Medical Systems SCS 510(k) number: K063324 Regulation Number: 21 CFR 892.1750 Computed tomography X-Ray system 21 CFR 892.1… | 2007 |
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 |
|---|---|---|---|
| K251883 | MIM – LesionID Pro | 2025 | 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?
- The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K251883 (Mim Software, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K063324.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response. PET VCAR automatically highlights and bookmarks PET defined regions of interest based on user-defined threshold settings. The software can be used for visualization and analytical monitoring of disease progression or response to treatment or therapy usingz multi…
Read the full statement (139 words)
PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to
assist in diagnosis, staging, treatment planning and monitoring treatment response. PET VCAR automatically highlights
and bookmarks PET defined regions of interest based on user-defined threshold settings. The software can be used for
visualization and analytical monitoring of disease progression or response to treatment or therapy usingz multi exam
comparison. The software is designed to measure Standard Uptake Value (SUV) and volume for any PET defined
metabolic activity. The software automatically propagates bookmarks from one time point to another for the purpose of
improving analysis and workflow, which is designed to allow clinicians to make informed follow-up decisions in an
efficient manner. PET VCAR does not provide or claim any automatic detection or automatic diagnosis of abnormal
anatomy, structure or function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211247: Pet Vcar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211247
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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