MR 5300 and MR 7700 R11 MR Systems— 510(k) K223442

Substantially Equivalent

Philips Medical Systems Nederlands B.V.

FDA 510(k) clearance K223442 for MR 5300 and MR 7700 R11 MR Systems, Substantially Equivalent on 2022-12-23. Applicant: Philips Medical Systems Nederlands B.V..

Clearance details

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

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.