FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Rayvolve PTX-PE
K Number: K243808
·
Decision Mar 21, 2025
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
39
Applicant Total
3
Review Days
100
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Basic Information
- Device Name
- Rayvolve PTX-PE
- K Number
- K243808
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2080
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AZmed
- Date Received
- December 11, 2024
- Decision Date
- March 21, 2025
- Product Code
- QFM
- 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 |
|---|---|---|---|
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | FDA class 2 | Radiology |
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