510(k) · Cleared
Recalled · Class II · 2013Pet Vcar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · JAK System, X-Ray, Tomography, Computed
Cleared on Mar 23, 2007 as substantially equivalent to K041521 (General Electric Medical Systems, 2004) and 2 other predicates after a 140-day review. Its family tree reaches back 6 generations to 1991. 1 of the 219 devices in its family, counting itself, has a Class I recall. 204 later devices descend from it. It has been recalled once.
- Decided
- Mar 23, 2007
- Review
- 140 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 6 generations to K913770 (1991). 14 ancestors in all, the oldest K871859 (1987). 204 later devices descend from it, 3 citing it directly. 1 of the 219 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 4 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 3 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 2 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 1 generation backK042694 Advanced Lung Analysis IIGE Medical Systems · 2004
- This deviceK063324 Pet VcarGE Healthcare · 2007
- Descendant · cites it directly · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 2 generations on · 76 of its ownK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- Descendant · 2 generations on · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
- Descendant · 3 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- Descendant · 2 generations on · 54 of its ownK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
Showing 5 of 204 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…6 generations on · 2025
Most influential descendants
Showing 5 of 204 · See all- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · cites it directly200descendants
- K101749Syngo Trued SoftwareSiemens Medical Solutions · 2010 · 2 generations on76descendants
- K101228Mirada XDMirada Medical, Ltd. · 2010 · 2 generations on70descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 3 generations on63descendants
- K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010 · 2 generations on54descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −5 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −4 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −3 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −2 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −1 | K042694 | Advanced Lung Analysis II | GE Medical Systems | 2004 | — |
| 0 (this device) | K063324 | Pet Vcar | GE Healthcare | 2007 | — |
| +1 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +2 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| +2 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| +3 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| +2 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 0 |
| 2016 | 8 | 0 |
| 2017 | 9 | 0 |
| 2018 | 15 | 0 |
| 2019 | 13 | 0 |
| 2020 | 20 | 0 |
| 2021 | 14 | 0 |
| 2022 | 21 | 0 |
| 2023 | 17 | 0 |
| 2024 | 18 | 0 |
| 2025 | 22 | 1 |
| 2026 | 22 | 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 |
|---|---|---|---|
| * | K041521 | Volume Viewer PlusSummary page 1…ent to the devices listed below: Model: Volume Viewer Plus Manufacturer: General Electric Medical Systems 510 (k): K041521 Model: Advanced Lung Analysis II Manufacturer: General Electric Medical Systems 510 (k)… | 2004 |
| * | K042694 | Advanced Lung Analysis IISummary page 1…(k): K041521 Model: Advanced Lung Analysis II Manufacturer: General Electric Medical Systems 510 (k): K042694 Model: Advantage Fusion Manufacturer: General Electric Medical Systems 510 (k):… | 2004 |
| * | K983256 | Advantage Windows (AW) FusionSummary page 1…510 (k): K042694 Model: Advantage Fusion Manufacturer: General Electric Medical Systems 510 (k): K983256 1/3… | 1998 |
What descends from it? (204)
See all 2043 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 9, 2013 | Class II | Z-1551-2013 | Software design | GE Healthcare has recently become aware of a potential safety issue with respect to the automated PERCIST response criteria calculation applied in the PET VCAR application on Advantage Workstation or AW Server. |
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.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K091373 (Siemens Medical Solutions USA, Inc., 2009) has gone furthest, with 200 descendants of its own.
- 16 other devices also cite its predicate K041521.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
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. The 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 using…
Read the full statement (182 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. The 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 using 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. PET VCAR offers a tool called Interactive Data Analysis (IDA) spreadsheet that compiles and manages all the analytical information in an organized and interactive design. The IDA is synchronized with the image display layouts offering quick measurement I image visual validation. PET VCAR's workflow 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/K063324 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063324: Pet Vcar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063324
Report an extraction error
Are you the manufacturer?
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