BoneMetrics (US)— 510(k) K241593

Substantially Equivalent

Gleamer Sas

FDA 510(k) clearance K241593 for BoneMetrics (US), Substantially Equivalent on 2025-02-05. Applicant: Gleamer Sas. Device class: 2.

Clearance details

Applicant: Gleamer Sas
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-06-03
Decision date: 2025-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

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 Gleamer Sas

K241620 — ChestView US2025-02-27

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