MOBINEURO Alita Intraoperative MRI System— 510(k) K223875

Name: FDA 510(k) clearance K223875
Creator: U.S. Food and Drug Administration
Published: 2023-03-20

Substantially Equivalent

Sino Canada Health Engineering Research Institute (Hefei)

FDA 510(k) clearance K223875 for MOBINEURO Alita Intraoperative MRI System, Substantially Equivalent on 2023-03-20. Applicant: Sino Canada Health Engineering Research Institute (Hefei). Device class: 2.

Clearance details

Applicant: Sino Canada Health Engineering Research Institute (Hefei)
Product code: Product code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2022-12-23
Decision date: 2023-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hefei, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNH

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K262902 — ECHELON Synergy2026-10-09
K260092 — Vista AI Scan2026-10-07
K261612 — SwiftSight-BodyComposition2026-10-01
K261283 — APERTO Lucent MRI System2026-09-16
K261758 — Embrace Vision Neonatal MRI System2026-09-16

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.