510(k) Report

510(k) · Cleared

Cleared

MeVis Liver Suite

K232045510(k) TraditionalCleared Oct 27, 2023109-day reviewClass II21 CFR 892.1750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

MeVis Medical Solutions AG · JAK System, X-Ray, Tomography, Computed

Cleared on Oct 27, 2023 as substantially equivalent to K133643 (Siemens Medi Cal Solutions, Inc., 2014) and 1 other predicate after a 109-day review. Its family tree reaches back 10 generations to 1996.

Decided
Oct 27, 2023
Review
109 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
2

Its longest line of descent runs back 10 generations to K954874 (1996). 74 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2014: 1 other ancestor2007: 1 other ancestor2006: 2 other ancestors2005: 2 other ancestors2004: 6 other ancestors2003: 3 other ancestors2002: 5 other ancestors2001: 8 other ancestors2000: 4 other ancestors1996: 6 other ancestors1998: 4 other ancestors1997: 3 other ancestors1991: 4 other ancestors1999: 2 other ancestors1995: 3 other ancestors1994: 2 other ancestors1993: 3 other ancestors1987: 1 other ancestor1992: 2 other ancestors1990: 1 other ancestor1989: 1 other ancestorReference device: K193562 · AI-Rad Companion Organs RT · Siemens Medical Solutions USA, Inc. · 2020K954874 · Spectef Protocol · GE Medical Systems · 1996K980914 · Emory Cardiac Tool Box · Emory University · 1998K992450 · Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers · Emory University · 1999K014033 · Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers · Syntermed, Inc. · 2002K040141 · Emory Cardiac Toolbox Version 2.6 · Syntermed, Inc. · 2004K052379 · Mim 3.5 (Circa) · Mimvista Corp. · 2005K060816 · Mim 4.0 (Neuro · Mimvista Corp. · 2006 · recalledK071964 · Mim 4.1 (Seastar) · Mimvista Corp. · 2007 · recalledK103576 · Mim 5.2 (Brachy) · Mim Software, Inc. · 2011K173420 · Radiomics App v1.0 · Microsoft Corp. · 20171990200020102020
  1. Root · 10 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
  2. 6 generations between
  3. 3 generations backK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
  4. 2 generations backK103576 Mim 5.2 (Brachy)Mim Software, Inc. · 2011
  5. 1 generation backK173420 Radiomics App v1.0Microsoft Corp. · 2017
  6. This deviceK232045 MeVis Liver SuiteMeVis Medical Solutions AG · 2023
Show all 10 generations
  1. Root · 10 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
  2. 9 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
  3. 8 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
  4. 7 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
  5. 6 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
  6. 5 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
  7. 4 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
  8. 3 generations backK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
  9. 2 generations backK103576 Mim 5.2 (Brachy)Mim Software, Inc. · 2011
  10. 1 generation backK173420 Radiomics App v1.0Microsoft Corp. · 2017
  11. This deviceK232045 MeVis Liver SuiteMeVis Medical Solutions AG · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K954874Spectef ProtocolGE Medical Systems1996—
−9K980914Emory Cardiac Tool BoxEmory University1998—
−8K992450Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University1999—
−7K014033Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc.2002—
−6K040141Emory Cardiac Toolbox Version 2.6Syntermed, Inc.2004—
−5K052379Mim 3.5 (Circa)Mimvista Corp.2005—
−4K060816Mim 4.0 (NeuroMimvista Corp.20061
−3K071964Mim 4.1 (Seastar)Mimvista Corp.20072
−2K103576Mim 5.2 (Brachy)Mim Software, Inc.2011—
−1K173420Radiomics App v1.0Microsoft Corp.2017—
0 (this device)K232045MeVis Liver SuiteMeVis Medical Solutions AG2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198910
199010
199140
199220
199330
199420
199530
199660
199730
199840
199920
200040
200180
200250
200330
200460
200520
200620
200710
201410
FIG. 1 — Lineage of K232045, 1996–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K133643Syngo, CT Liver Analysis
Summary page 6
…Page 1 3 Primary Predicate Device 510(k) Number Primary Predicate Device Product Code K133643 syngo.CT Liver Analysis JAK 4 Secondary Predicate Device(s) 510(k)…
Siemens Medi Cal Solutions, Inc.2014—
*K173420Radiomics App v1.0
Summary page 6
…JAK 4 Secondary Predicate Device(s) 510(k) Number Secondary Predicate Device Product Code K173420 Radiomics App v1.0 LLZ 5 Reference Device 1 510(k) Number R…
Microsoft Corp.2017—
†K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.2020—

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 27 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
  • 16 of the 74 ancestors have a recall of any class.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · JAK

27in 2025

2007: 142008: 262009: 152010: 72011: 162012: 282013: 172014: 302015: 302016: 252017: 292018: 242019: 282020: 302021: 202022: 302023: 272024: 262025: 272026 (partial year): 21
2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007: 27 days median2008: 42 days median2009: 31 days median2010: 92 days median2011: 155 days median2012: 121 days median2013: 132 days median2014: 200 days median2015: 140 days median2016: 129 days median2017: 96 days median2018: 114 days median2019: 94 days median2020: 112 days median2021: 145 days median2022: 131 days median2023: 139 days median2024: 141 days median2025: 141 days median2026 (partial year): 167 days median
2007high 200 (2014) · low 27 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAK

17in 2025

2007: 112008: 162009: 292010: 512011: 342012: 232013: 112014: 102015: 282016: 442017: 332018: 102019: 52020: 82021: 152022: 92023: 92024: 202025: 172026 (partial year): 23
2007high 51 (2010) · low 5 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAK

219in 2025

2007: 762008: 1202009: 1052010: 1192011: 2052012: 1922013: 4142014: 3082015: 4542016: 3652017: 3382018: 5432019: 2332020: 1772021: 2612022: 1992023: 3102024: 2122025: 219
2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714271176
2008264216120
2009153129105
201079251119
20111615534205
20122812123192
20131713211414
20143020010308
20153014028454
20162512944365
2017299633338
20182411410543
201928945233
2020301128177
20212014515261
2022301319199
2023271399310
20242614120212
20252714117219
20262116723—

What is it indicated for?

MeVis Liver Suite is an image analysis software and intended to be used for visualization of hepatic imaging studies derived from CT and MR scanning devices (image source: single- and multiframe DICOM). MeVis Liver Suite supports physicians in their workflow for evaluating the liver, related vascular anatomy, and the volume of liver and liver vascular territories for treatment planning, preoperative evaluation of surgery strategies, and post-procedure or…

Read the full statement (745 words)

MeVis Liver Suite is an image analysis software and intended to be used for visualization of hepatic imaging studies derived from CT and MR scanning devices (image source: single- and multiframe DICOM).

MeVis Liver Suite supports physicians in their workflow for evaluating the liver, related vascular anatomy, and the volume of liver and liver vascular territories for treatment planning, preoperative evaluation of surgery strategies, and post-procedure or therapy follow-up assessment of the hepatic system and related vascular structures.

MeVis Liver Suite supports image analysis for multiphase contrast enhanced CT, dynamic contrast enhanced MRI, and MRCP. MeVis Liver Suite only allows import of homogenous image series (i.e., image and pixel size must be constant within each series) and with orthogonal image matrix (without a gantry tilt). Images with a resolution of > 5mm slice spacing are not suitable for image analysis with MeVis Liver Suite.

MeVis Liver Suite can be used for manual segmentation, user-defined manual labeling, and 3D visualization of:

- abdominal organs (i.e., liver, stomach, duodenum, spleen, kidney, gallbladder, and pancreas)

- liver related vascular structures (i.e., bile ducts, hepatic artery, hepatic vein, portal vein, and inferior vena cava)

- lesions inside and adjacent to the liver

The tools for manual segmentation and 3D visualization are applicable for CT and MR imaging studies.

In addition to the manual segmentation tools, MeVis Liver Suite provides AI based semi-automatic pre-segmentation tools for liver, hepatic artery, hepatic vein, and portal vein restricted to CT scans of potential living liver donors with healthy livers and intended for:

- Liver: contrast enhanced late-venous and venous phase

- Hepatic vein: contrast enhanced late-venous and venous phase

- Portal vein: contrast enhanced late-venous and venous phase

- Hepatic artery: contrast enhanced arterial phase

Using MeVis Liver Suite, users can evaluate the segmented objects by exploring, calculating, and manually correcting:

- the volume of the segmented abdominal organs (see above)

- the volume of the segmented lesions inside and adjacent to the liver

- the volume of the manually defined parts of the liver

- by defining separation planes (“separation proposals”)

- from vascular territories that are derived from the user-defined labeling of the liver related vascular structures

- 3D visualizations of user-defined (vascular) tumor margins (coloring of area - based on user-defined margin sizes/distances - between the edges of user-defined lesions in relation to the edges of user-defined vascular structures of the liver)

- based on user provided values, calculation of liver volume to body weight ratios (i.e., estimated weight for remnant or graft, body surface area, graft to recipient body weight ratio, graft to SLV ratio, remnant to body weight ratio).

Using a manual spatial registration of the images, the segmented objects (created on different CT phases and MRI sequences) can be visualized together.

The information created with MeVis Liver Suite is intended to be used only in addition to the original images, clinical data, and the real anatomical and clinical situation. Physicians make all final patient management, assessment, and treatment decisions.

MeVis Liver Suite is not intended for the anatomical systems integumentary, skeletal, muscular, lymphatic, respiratory, nervous, reproductive, and cardiovascular (excluding hepatic).

MeVis Liver Suite does not support the following application areas: real time viewing, diagnostic review, image manipulation, optimization, virtual colonoscopy, and automatic lesion detection.

MeVis Liver Suite does not utilize high-resolution displays or display drivers and should not be used as a replacement for a PACS workstation.

Intended Patient Population:

The intended patients for MeVis Liver Suite are oncologic patients or hepatic donor/transplant patients. CT or MR imaging with contrast agents need to be possible for analysis of vascular structures inside the liver. The age group for the intended patient population is 18 or older.

In addition, the semi-automatic pre-segmentation tools are restricted to CT scans of potential living liver donors with healthy livers.

Intended Part of the Body:

Images supported for the intended medical indication include the abdominal body part with the liver and related vascular structures (bile ducts, hepatic artery, hepatic vein, portal vein, inferior vena cava).

Intended User Profile:

The intended users are radiologists and surgeons.

Intended Use Environment:

The use environment is expected to be in an office environment under typical office conditions in hospitals or medical practices.

Operation Principle:

The software acts as modality for display of CT or MR imaging data, and for visualization of the image analysis results on a computer system. MeVis Liver Suite does not come into direct contact or indirect contact with patients or other medical devices.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K232045: MeVis Liver Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232045

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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