K223442

Substantially Equivalent

MR 5300 and MR 7700 R11 MR Systems

Applicant: Philips Medical Systems Nederlands B.V.
Product code: LNH
Advisory panel: Radiology
Date received: 2022-11-14
Decision date: 2022-12-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Best, NL

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.