DigitalDiagnost C90
FDA 510(k) clearance K202564 · decided 2020-09-30
Clearance details
- K-number
- K202564
- Device name
- DigitalDiagnost C90
- Applicant
- Philips Medical Systems Dmc GmbH
- Decision
- Substantially Equivalent
- Date received
- 2020-09-04
- Decision date
- 2020-09-30
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hamburg, DE
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. recall (Z-2354-2026) | Philips North America Llc | 2026-06-05 |
| DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 71203 recall (Z-0465-2026) | Philips Medical Systems DMC GmbH | 2025-11-07 |
| DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and expo recall (Z-0275-2024) | Philips North America Llc | 2023-11-08 |
| DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export recall (Z-0276-2024) | Philips North America Llc | 2023-11-08 |
| DigitalDiagnost C90, Model No. 712034 and 712035 recall (Z-2042-2023) | Philips North America Llc | 2023-06-30 |
| DigitalDiagnost C90 High Performance. radiography and fluoroscopy system recall (Z-1328-2022) | Philips Medical Systems DMC GmbH | 2022-07-12 |
| DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system recall (Z-1329-2022) | Philips Medical Systems DMC GmbH | 2022-07-12 |