FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
DigitalDiagnost C90
K Number: K182973
·
Decision Jan 11, 2019
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
18
Review Days
77
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Basic Information
- Device Name
- DigitalDiagnost C90
- K Number
- K182973
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Medical Systems Dmc GmbH
- Date Received
- October 26, 2018
- Decision Date
- January 11, 2019
- Product Code
- MQB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
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|---|---|---|---|
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| K232910 | CombiDiagnost R90 | Oct 19, 2023 | Substantially Equivalent |
| K212186 | Philips Radiology Smart Assistant | Dec 13, 2021 | Substantially Equivalent |
| K212837 | ProxiDiagnost N90 | Sep 21, 2021 | Substantially Equivalent |
| K210692 | DigitalDiagnost | Apr 2, 2021 | Substantially Equivalent |
| K203087 | CombiDiagnost R90 | Dec 3, 2020 | Substantially Equivalent |
| K202564 | DigitalDiagnost C90 | Sep 30, 2020 | Substantially Equivalent |
| K173433 | ProxiDiagnost N90 | Feb 5, 2018 | Substantially Equivalent |