FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
CombiDiagnost R90
K Number: K232910
·
Decision Oct 19, 2023
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
297
Applicant Total
15
Review Days
30
Basic Information
- Device Name
- CombiDiagnost R90
- K Number
- K232910
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Medical Systems DMC GmbH
- Date Received
- September 19, 2023
- Decision Date
- October 19, 2023
- Product Code
- JAA
- 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 |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
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| K Number | Device Name | ||
|---|---|---|---|
| K233662 | Radiography 7300 C | Jun 13, 2024 | Substantially Equivalent |
| K233678 | Radiography 7000 M | Feb 14, 2024 | Substantially Equivalent |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400) | Jan 11, 2024 | 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 |
| K182973 | DigitalDiagnost C90 | Jan 11, 2019 | Substantially Equivalent |
| K173433 | ProxiDiagnost N90 | Feb 5, 2018 | Substantially Equivalent |