ProxiDiagnost N90— 510(k) K173433
Substantially EquivalentPhilips Medical Systems Dmc GmbH
FDA 510(k) clearance K173433 for ProxiDiagnost N90, Substantially Equivalent on 2018-02-05. Applicant: Philips Medical Systems Dmc GmbH. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems Dmc GmbH
- Product code
- Code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hamburg, DE
Recent devices under product code OWB
view allMore clearances from Philips Medical Systems Dmc GmbH
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
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 K173433
K-number listed on FDA's recall record- Z-1587-2023 — ProxiDiagnost N90 R.1.0
- 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-1356-2023 — ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
- Z-0240-2022 — ProxiDiagnost N90 is multi-functional general R/F systems.
- Z-0727-2021 — ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
- Z-2256-2020 — ProxiDiagnost N90, UDI 706100
- Z-3023-2020 — ProxiDiagnost N90
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173433.
Data sourced from openFDA. This site is unofficial and independent of the FDA.