Cleared Traditional

TBS INSIGHT

K121716 · Medimaps Group SA · Radiology
Oct 2012
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K121716 is an FDA 510(k) clearance for the TBS INSIGHT, 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 October 5, 2012, 116 days after receiving the submission on June 11, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1170.

Submission Details

510(k) Number K121716 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 2012
Decision Date October 05, 2012
Days to Decision 116 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