MeVis Liver Suite
K232045MeVis Medical Solutions AG · cleared 2023-10-27 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“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).”
source quote (p.7)
“Additionally, the user can use AI based semi-automatic pre-segmentation of liver and liver related vascular structures to create a segmentation proposal. The semi-automatic pre-segmentation uses locked/non adaptive AI networks.”
source quote (p.7)
“The semi-automatic pre-segmentation uses locked/non adaptive AI networks.”
Validation studies (5)
Retrospective clinical
sample size not stated
endpoints: DICE score; Hausdorff (HD) value
Bench
sample size not stated
Reader study (MRMC)
sample size not stated
endpoints: qualitative scoring
Bench
sample size not stated
endpoints: accuracy of volume
Retrospective clinical
sample size not stated
endpoints: precision of volume calculation in terms of repeatability
Reported performance (1 observation)
source quote (p.16)
“For semi-automatic AI pre-segmentation of the liver, MeVis Liver Suite achieved a mean and median DICE score > 85% with a median 95% Hausdorff (HD) value of <2.0 mm. Subgroup analysis indicates that the AI algorithm generalize well across all subgroups. Compared to the reference device Al-Rad Companion Organs RT (K193562), both the DICE score and the HD value were similar in nature and achieved appropriate quality. As it can be seen in Table 3, the achieved performance of the MeVis Liver Suite liver AI pre-segmentation algorithm and reference device are comparable in DICE and Hausdorff Distance. Table 3 Performance comparison of liver AI pre-segmentation between MeVis Liver Suite and reference device. MeVis Liver Suite Median: 0.98 Mean: 0.98”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (GE Medical Systems, LLC, initiated 2026-03-26): "GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98738
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2026-03-07): "Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98588
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (Siemens Medical Solutions USA, Inc, initiated 2025-12-19): "To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98206
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2025-09-25): "Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axia" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97699
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (Philips North America Llc, initiated 2025-05-29): "Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97010
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (, initiated 2025-05-23): "Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:96967
- …and 3 more.
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).