LiverMultiScan (LMSv3)— 510(k) K190017

Name: FDA 510(k) clearance K190017
Creator: U.S. Food and Drug Administration
Published: 2019-06-27

Substantially Equivalent

Perspectum Diagnostics, Ltd.

FDA 510(k) clearance K190017 for LiverMultiScan (LMSv3), Substantially Equivalent on 2019-06-27. Applicant: Perspectum Diagnostics, Ltd.. Device class: 2.

Clearance details

Applicant: Perspectum Diagnostics, Ltd.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2019-01-03
Decision date: 2019-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNH

view all

K262622 — Swoop® Portable MR Imaging® System2026-08-19
K254250 — MagicScan-1.5, GreenMR Serenity 1.5T2026-08-17
K253808 — AIR Recon DL2026-08-13
K260852 — MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise; MAGNETOM Flow.Pure2026-07-31
K261331 — I-Genius (100019400)2026-07-31

More clearances from Perspectum Diagnostics, Ltd.

view all

K183133 — MRCP+ v1.02019-01-09
K172685 — LiverMultiScan2017-11-21

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.