FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Ortho Device, ADAPTIX 3D Orthopedic Imaging System
K Number: K221949
·
Decision Jan 26, 2023
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
41
Applicant Total
3
Review Days
205
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Basic Information
- Device Name
- Ortho Device, ADAPTIX 3D Orthopedic Imaging System
- K Number
- K221949
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1740
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pausch Medical GmbH
- Date Received
- July 5, 2022
- Decision Date
- January 26, 2023
- Product Code
- IZF
- 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 |
|---|---|---|---|
| IZF | System, X-Ray, Tomographic | FDA class 2 | Radiology |
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