ProxiDiagnost N90 / Precision CRF (706110, 706400)— 510(k) K233945

Substantially Equivalent

Philips Medical Systems Dmc GmbH

FDA 510(k) clearance K233945 for ProxiDiagnost N90 / Precision CRF (706110, 706400), Substantially Equivalent on 2024-01-11. Applicant: Philips Medical Systems Dmc GmbH.

Clearance details

Applicant
Philips Medical Systems Dmc GmbH
Product code
Code JAA
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Hamburg, DE
Download summary PDFView on FDA.gov ↗

Adverse events under product code JAA

product code JAA
Other
1
Total
1

Source: openFDA MAUDE database, through . 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.