FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Adaptix Ortho350
K Number: K252133
·
Decision Nov 6, 2025
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
41
Applicant Total
1
Review Days
122
Basic Information
- Device Name
- Adaptix Ortho350
- K Number
- K252133
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1740
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Adaptix Limited
- Date Received
- July 7, 2025
- Decision Date
- November 6, 2025
- Product Code
- IZF
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
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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