FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ProxiDiagnost N90
K Number: K173433
·
Decision Feb 5, 2018
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
319
Applicant Total
18
Review Days
95
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ProxiDiagnost N90
- K Number
- K173433
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Medical Systems Dmc GmbH
- Date Received
- November 2, 2017
- Decision Date
- February 5, 2018
- Product Code
- OWB
- 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 |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OWB), ordered by most recent decision date.
C-beam
FDA 510(k)
FDA Class 2
·Radiology
Intelligent NR
FDA 510(k)
FDA Class 2
·Radiology
ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno
FDA 510(k)
FDA Class 2
·Radiology
ARTIS genio floor; ARTIS icono.explore floor
FDA 510(k)
FDA Class 2
·Radiology
BELLIGER ACE
FDA 510(k)
FDA Class 2
·Radiology
Trinias
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Philips Medical Systems Dmc GmbH
| 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 |
| 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 |
| K182973 | DigitalDiagnost C90 | Jan 11, 2019 | Substantially Equivalent |