Cleared Traditional

K212365 - BoneView
(FDA 510(k) Clearance)

K212365 · Gleamer · Radiology
Mar 2022
Decision
214d
Days
Class 2
Risk

K212365 is an FDA 510(k) clearance for the BoneView, a Radiological Computer Assisted Detection/diagnosis Software For Fracture (Class II — Special Controls, product code QBS), submitted by Gleamer (Saint Mand?, FR). The FDA issued a Cleared decision on March 1, 2022, 214 days after receiving the submission on July 30, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2090.

Submission Details

510(k) Number K212365 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2021
Decision Date March 01, 2022
Days to Decision 214 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QBS — Radiological Computer Assisted Detection/diagnosis Software For Fracture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2090
Definition A Radiological Computer Assisted Detection And Diagnostic Software For Suspected Fracture Is An Image Processing Device Intended To Aid In The Detection, Localization, And/or Characterization Of Fracture On Acquired Medical Images (e.g. Radiography, Mr, Ct). The Device Detects, Identifies And/or Characterizes Fracture Based On Features Or Information Extracted From Images, And May Provide Information About The Presence, Location, And/or Characteristics Of The Fracture To The User. Primary Diagnostic And Patient Management Decisions Are Made By The Clinical User.