Bonelogic— 510(k) K223757

Substantially Equivalent

Disior, Ltd.

FDA 510(k) clearance K223757 for Bonelogic, Substantially Equivalent on 2023-12-08. 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: 2022-12-15
Decision date: 2023-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

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
K240642 — SMART Bun-Yo-Matic CT2024-06-20
K203290 — Bonelogic2021-02-05

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