K212837

Substantially Equivalent

ProxiDiagnost N90

Applicant: Philips Medical Systems Dmc GmbH
Product code: JAA
Advisory panel: Radiology
Date received: 2021-09-07
Decision date: 2021-09-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Hamburg, DE

Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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.