Cleared Traditional

TBS iNsight

K152299 · Medimaps Group SA · Radiology
Apr 2016
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K152299 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 April 29, 2016, 260 days after receiving the submission on August 13, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1170.

Submission Details

510(k) Number K152299 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2015
Decision Date April 29, 2016
Days to Decision 260 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