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. Device class: 2.

Clearance details

Applicant: Planmed OY
Product code: Code SFV
Device class: Class 2
Regulation: 21 CFR 892.1750
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 ↗

More clearances from Planmed OY

K211720 — Planmed Clarity 2D, Planmed Clarify S2022-07-18
K213278 — Planmed Verity2022-04-28
K192317 — Planmed Clarity 2D and Clarity S2020-10-23
K180918 — Planmed Verity2018-11-30
K163328 — Planmed Clarity2017-12-28

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