BoneView

Radiological Computer Assisted Detection/diagnosis Software For Fracture

Gleamer

The following data is part of a premarket notification filed by Gleamer with the FDA for Boneview.

Pre-market Notification Details

• Device ID: K212365
• 510k Number: K212365
• Device Name: BoneView
• Classification: Radiological Computer Assisted Detection/diagnosis Software For Fracture
• Applicant: Gleamer 5 Avenue Du Général De Gaulle Saint Mandé, FR 94160
• Contact: Antoine Tournier
• Correspondent: Antoine Tournier; Gleamer 5 Avenue Du Général De Gaulle Saint Mandé, FR 94160
• Product Code: QBS
• CFR Regulation Number: 892.2090 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-07-30
• Decision Date: 2022-03-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03770020839009	K212365	000