Planmed XFI— 510(k) K250318

Substantially Equivalent

Planmed OY

FDA 510(k) clearance K250318 for Planmed XFI, Substantially Equivalent on 2025-09-26. Applicant: Planmed OY.

Clearance details

Applicant: Planmed OY
Product code: Code SFV
Advisory panel: Radiology
Date received: 2025-02-04
Decision date: 2025-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.