FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Persona C HR
K Number: K250282
·
Decision Apr 30, 2025
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
319
Applicant Total
4
Review Days
89
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Basic Information
- Device Name
- Persona C HR
- K Number
- K250282
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- A.T.S. Applicazione Tecnologie Speciali S.R.L.
- Date Received
- January 31, 2025
- Decision Date
- April 30, 2025
- 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 |
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