ProxiDiagnost N90 / Precision CRF (706110, 706400)— 510(k) K233945
Substantially EquivalentPhilips 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. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems Dmc GmbH
- Product code
- Code JAA
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hamburg, DE
Recent devices under product code JAA
view allMore clearances from Philips Medical Systems Dmc GmbH
view allAdverse 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 →
Recalls naming K233945
K-number listed on FDA's recall record- Z-0461-2026 — ProxiDiagnost N90; Model Number: 706110;
- Z-0463-2026 — Precision CRF; Model Number: 706400;
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K233945.
Data sourced from openFDA. This site is unofficial and independent of the FDA.