510(k) K212837 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
ProxiDiagnost N90
| Applicant | Philips Medical Systems Dmc GmbH, Hamburg, DE |
| Decision | Substantially Equivalent, Sep 21, 2021 |
| Received | Sep 7, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212837
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2024 | Philips North America ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system
Ref:
(1)706100
(2)706110 Open, Classified |
JAA | None listed |
| Feb 9, 2024 | Philips North America ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system
Ref:706150 Open, Classified |
JAA | None listed |
| Nov 8, 2023 | Philips North America Llc ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system Open, Classified |
JAA | None listed |
| Apr 28, 2023 | Philips North America Llc Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system Open, Classified |
OWB | None listed |
| Jul 12, 2022 | Philips Medical Systems DMC GmbH ProxiDiagnost N90. radiography and fluoroscopy system Open, Classified |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.