Cleared Traditional

K121716 - TBS INSIGHT

K121716 is an FDA 510(k) clearance for TBS INSIGHT, manufactured by Medimaps Group SA. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 116-day FDA review.

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

K121716 is an FDA 510(k) clearance for the TBS INSIGHT. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Medimaps Group SA (Plan Les Ouates, CH). The FDA issued a Cleared decision on October 5, 2012 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1170 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medimaps Group SA devices

FDA 510(k) Submission Details - K121716

510(k) Number K121716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 107d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KGI Device Classification - Class 2, Special Controls

Product Code KGI Densitometer, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1170
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KGI Densitometer, Bone

All 65
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