Philips CombiDiagnost R90— 510(k) K163210
Substantially EquivalentPhilips Medical Systems Dmc GmbH
FDA 510(k) clearance K163210 for Philips CombiDiagnost R90, Substantially Equivalent on 2017-01-31. 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 K163210
K-number listed on FDA's recall record- Z-1588-2023 — CombiDiagnost R90 R.1.0
- Z-1087-2024 — CombiDiagnost R90 1.0 (709030)
- Z-1355-2023 — CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
- Z-1356-2023 — ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
- Z-1328-2020 — CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
- Z-1329-2020 — CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
- Z-0612-2019 — Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
- Z-0330-2018 — CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163210.
Data sourced from openFDA. This site is unofficial and independent of the FDA.