OASIS MRI System— 510(k) K192851

Substantially Equivalent

Hitachi Healthcare Americas

FDA 510(k) clearance K192851 for OASIS MRI System, Substantially Equivalent on 2020-02-21. Applicant: Hitachi Healthcare Americas.

Clearance details

Applicant: Hitachi Healthcare Americas
Product code: Code LNH
Advisory panel: Radiology
Date received: 2019-10-03
Decision date: 2020-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Twinsburg, OH, US

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.