CombiDiagnost R90— 510(k) K203087
Substantially EquivalentPhilips Medical Systems Dmc GmbH
FDA 510(k) clearance K203087 for CombiDiagnost R90, Substantially Equivalent on 2020-12-03. 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
- Traditional
- 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 K203087
K-number listed on FDA's recall record- Z-0271-2024 — CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
- Z-1589-2023 — CombiDiagnost R90 R1.1
- Z-1088-2024 — CombiDiagnost R90 1.1 (709031)
- Z-1355-2023 — CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
- Z-0241-2022 — CombiDiagnost R90 is multi-functional general R/F systems.
- Z-2357-2021 — CombiDiagnost R90 Software Version R1.0 and R1.1
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203087.
Data sourced from openFDA. This site is unofficial and independent of the FDA.