LiverMultiScan v5 (LMSv5)— 510(k) K213960

Substantially Equivalent

Perspectum

FDA 510(k) clearance K213960 for LiverMultiScan v5 (LMSv5), Substantially Equivalent on 2022-09-06. Applicant: Perspectum.

Clearance details

Applicant: Perspectum
Product code: Code LNH
Advisory panel: Radiology
Date received: 2021-12-17
Decision date: 2022-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.