510(k) · Cleared
ClearedHepatic Vcar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems SCS · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 22, 2014 as substantially equivalent to K041521 (General Electric Medical Systems, 2004) after a 146-day review. Its family tree reaches back 3 generations to 1987. 3 later devices descend from it.
- Decided
- Apr 22, 2014
- Review
- 146 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K871859 (1987). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK871859 CT9800 Quick 3D #B7919DAGeneral Electric Co. · 1987
- 2 generations backK972399 Advantage Windows Volume Rendering OptionGe Medical Systems, Inc. · 1997 · Recalled
- 1 generation backK041521 Volume Viewer PlusGeneral Electric Medical Systems · 2004 · Recalled
- This deviceK133649 Hepatic VcarGE Medical Systems SCS · 2014
- Descendant · cites it directly · 1 of its ownK193281 Hepatic VCARGE Medical Systems SCS · 2020
- Descendant · 2 generations on · 0 of its ownK211180 Liver SuiteGE Medical Systems SCS · 2022
- Descendant · cites it directly · 0 of its ownK201092 LSNImaging Biometrics, LLC · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871859 | CT9800 Quick 3D #B7919DA | General Electric Co. | 1987 | — |
| −2 | K972399 | Advantage Windows Volume Rendering Option | Ge Medical Systems, Inc. | 1997 | 1 |
| −1 | K041521 | Volume Viewer Plus | General Electric Medical Systems | 2004 | 2 |
| 0 (this device) | K133649 | Hepatic Vcar | GE Medical Systems SCS | 2014 | — |
| +1 | K193281 | Hepatic VCAR | GE Medical Systems SCS | 2020 | — |
| +2 | K211180 | Liver Suite | GE Medical Systems SCS | 2022 | — |
| +1 | K201092 | LSN | Imaging Biometrics, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2022 | 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 JAK? 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? (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 |
|---|---|---|---|
| * | K041521 | Volume Viewer PlusSummary page 1…epatic VCAR Common/Usual Name: Hepatic VCAR Classification Names: 21CFR 892.1750, Radiology Product Code: JAK Predicate Device(s): K041521 - Volume Viewer Plus Devie Decripion:Hepatic VCAR isa CT image analysis software package that all… | 2004 |
What descends from it? (3)
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)
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 27 years and passes through 4 companies; a new generation was cleared every 9.8 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K193281 (GE Medical Systems SCS, 2020) has gone furthest, with 1 descendant 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. 2014, 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?
Hepatic VICAR is a CT image analysis software package that allows the analysis and visualization of Liver CT data derived fromn DICOM 3.0 compliant CT scans. Hepatic VCAR is designed for the purpose of assessing liver morphology, including liver lesion, provided the lesion has different CT appearance from surrounding liver tissue; and its change over time through automated tools for liver, liver lobe, liver segments and liver lesion segmentation and…
Read the full statement (122 words)
Hepatic VICAR is a CT image analysis software package that allows the analysis and visualization of Liver CT data derived fromn DICOM 3.0 compliant CT scans. Hepatic VCAR is designed for the purpose of assessing liver morphology, including liver lesion, provided the lesion has different CT appearance from surrounding liver tissue; and its change over time through automated tools for liver, liver lobe, liver segments and liver lesion segmentation and measurement. It is intended for use by clinicians to process, review, archive, print and distribute liver CT studies.
This software will assist the user by providing initial 3D segmentation, vessel analysis, visualization, and quantitative analysis of liver anatomy. The user has the ability to adjust the contour and confirm the final segmentation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133649: Hepatic Vcar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133649
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