Philips CombiDiagnost R90
FDA 510(k) clearance K163210 · decided 2017-01-31
Clearance details
- K-number
- K163210
- Device name
- Philips CombiDiagnost R90
- Applicant
- Philips Medical Systems Dmc GmbH
- Decision
- Substantially Equivalent
- Date received
- 2016-11-15
- Decision date
- 2017-01-31
- Days to decision
- 77 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| CombiDiagnost R90 1.0 (709030) recall (Z-1087-2024) | PHILIPS MEDICAL SYSTEMS | 2024-02-14 |
| CombiDiagnost R90 R.1.0 recall (Z-1588-2023) | Philips North America | 2023-05-15 |
| CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 an recall (Z-1355-2023) | Philips North America Llc | 2023-04-10 |
| ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 an recall (Z-1356-2023) | Philips North America Llc | 2023-04-10 |
| CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, di recall (Z-1328-2020) | Philips Medical Systems Gmbh, DMC | 2020-02-20 |
| CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, di recall (Z-1329-2020) | Philips Medical Systems Gmbh, DMC | 2020-02-20 |