ProxiDiagnost N90
FDA 510(k) clearance K212837 · decided 2021-09-21
Clearance details
- K-number
- K212837
- Device name
- ProxiDiagnost N90
- Applicant
- Philips Medical Systems Dmc GmbH
- Decision
- Substantially Equivalent
- Date received
- 2021-09-07
- Decision date
- 2021-09-21
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- JAA
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hamburg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref recall (Z-1072-2024) | Philips North America | 2024-02-09 |
| ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system recall (Z-1073-2024) | Philips North America | 2024-02-09 |
| ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system recall (Z-0280-2024) | Philips North America Llc | 2023-11-08 |
| Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A m recall (Z-1477-2023) | Philips North America Llc | 2023-04-28 |
| ProxiDiagnost N90. radiography and fluoroscopy system recall (Z-1325-2022) | Philips Medical Systems DMC GmbH | 2022-07-12 |