Cleared Traditional

TBS iNsight (V4)

K243218 · Medimaps Group SA · Radiology
Jan 2025
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K243218 is an FDA 510(k) clearance for the TBS iNsight (V4), a Densitometer, Bone (Class II — Special Controls, product code KGI), submitted by Medimaps Group SA (Plan-Les-Ouates, CH). The FDA issued a Cleared decision on January 17, 2025, 105 days after receiving the submission on October 4, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1170.

Submission Details

510(k) Number K243218 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2024
Decision Date January 17, 2025
Days to Decision 105 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KGI — Densitometer, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1170