ProxiDiagnost N90— 510(k) K212837
Substantially EquivalentPhilips Medical Systems Dmc GmbH
FDA 510(k) clearance K212837 for ProxiDiagnost N90, Substantially Equivalent on 2021-09-21. 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 K212837
K-number listed on FDA's recall record- Z-1072-2024 — ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
- Z-1073-2024 — ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
- Z-0280-2024 — ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system
- Z-1477-2023 — Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system
- Z-1325-2022 — ProxiDiagnost N90. radiography and fluoroscopy system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K212837.
Data sourced from openFDA. This site is unofficial and independent of the FDA.