SMART Bun-Yo-Matic CT— 510(k) K240642

Substantially Equivalent

Disior, Ltd.

FDA 510(k) clearance K240642 for SMART Bun-Yo-Matic CT, Substantially Equivalent on 2024-06-20. 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: 2024-03-06
Decision date: 2024-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki Uusimaa, FI

Download summary PDF View on FDA.gov ↗

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More clearances from Disior, Ltd.

K253764 — ENOS Software Guided External Fixation System2026-02-26
K250023 — SMART PCFD2025-09-29
K240736 — SMART Bun-Yo-Matic X-Ray2024-07-02
K223757 — Bonelogic2023-12-08
K203290 — Bonelogic2021-02-05

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