DigitalDiagnost C50
FDA 510(k) clearance K201725 · decided 2020-07-10
Clearance details
- K-number
- K201725
- Device name
- DigitalDiagnost C50
- Applicant
- Philips Healthcare (Suzhou) Co., Lit.
- Decision
- Substantially Equivalent
- Date received
- 2020-06-23
- Decision date
- 2020-07-10
- Days to decision
- 17 days
- Clearance type
- Special
- Product code
- KPR
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Suzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human a recall (Z-1382-2023) | Philips North America Llc | 2023-04-12 |
| DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatom recall (Z-1383-2023) | Philips North America Llc | 2023-04-12 |
| DigitalDiagnost C50 1.1 recall (Z-1563-2022) | Philips North America Llc | 2022-09-01 |