Planmed XFI
FDA 510(k) clearance K250318 · decided 2025-09-26
Clearance details
- K-number
- K250318
- Device name
- Planmed XFI
- Applicant
- Planmed OY
- Decision
- Substantially Equivalent
- Date received
- 2025-02-04
- Decision date
- 2025-09-26
- Days to decision
- 234 days
- Clearance type
- Traditional
- Product code
- SFV
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Helsinki, FI
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.