MeVis Liver Suite

Evidence summary

Validation and verification covered successful testing of the performance and functionality of the subject device with respect to conformance to specifications. Human factors and usability engineering included formative and summative evaluation with the intended user group, and user acceptance tests were conducted. The AI pre-segmentation and volume calculation were validated, and the results of performance, functional, and validation testing demonstrate that the subject device meets the specification and intended use and is substantially equivalent. No clinical testing has been conducted to demonstrate substantial equivalence.

• FDA source
• Exact FDA submission
• Checked 2026-09-19

The replacement uses only the exact packet's verification, validation, usability, acceptance, AI pre-segmentation, volume-calculation, substantial-equivalence, and clinical-testing statements.

• Source

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Postmarket safety review

The exact-identifier FDA recall query returned no native recall record for K232045. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.

• Public source
• Exact FDA submission
• Checked 2026-09-08

• Source

• Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
• Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
• Verify pricing and total cost: No public price or quote for the exact K232045 configuration was established in this review.
• Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
• Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, vendor product page, fda device recall, literature index, trial registry, fda decision summary packet, pubmed, clinical trials, openfda device recall