510(k) K163210 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips CombiDiagnost R90
| Applicant | Philips Medical Systems Dmc GmbH, Hamburg, DE |
| Decision | Substantially Equivalent, Jan 31, 2017 |
| Received | Nov 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163210
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2024 | PHILIPS MEDICAL SYSTEMS CombiDiagnost R90 1.0 (709030) Open, Classified |
JAA | None listed |
| May 15, 2023 | Philips North America CombiDiagnost R90 R.1.0 Open, Classified |
JAA | None listed |
| Apr 10, 2023 | Philips North America Llc CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031 Open, Classified |
JAA | None listed |
| Apr 10, 2023 | Philips North America Llc ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110 Open, Classified |
JAA | None listed |
| Feb 20, 2020 | Philips Medical Systems Gmbh, DMC CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose. Terminated |
JAA | None listed |
| Feb 20, 2020 | Philips Medical Systems Gmbh, DMC CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose. Terminated |
JAA | None listed |
| Nov 7, 2018 | Philips Medical Systems Gmbh, DMC Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030
Stationary Fluoroscopic X-ray System Terminated |
JAA | None listed |
| Oct 19, 2017 | Philips Electronics North America Corporation 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 s Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.