SMART PCFD— 510(k) K250023

Substantially Equivalent

Disior, Ltd.

FDA 510(k) clearance K250023 for SMART PCFD, Substantially Equivalent on 2025-09-29. Applicant: Disior, Ltd.. Device class: 2.

Clearance details

Applicant: Disior, Ltd.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-01-03
Decision date: 2025-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki Uusimaa, FI

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

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K260811 — Heartvue.Proton2026-08-26

More clearances from Disior, Ltd.

K253764 — ENOS Software Guided External Fixation System2026-02-26
K240736 — SMART Bun-Yo-Matic X-Ray2024-07-02
K240642 — SMART Bun-Yo-Matic CT2024-06-20
K223757 — Bonelogic2023-12-08
K203290 — Bonelogic2021-02-05

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