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TBS Insight

by medimaps group SA 2 variants

510(k) K121716

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121716 Date5 Oct 2012ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KGI
Device class
Class II
Regulation
21 CFR Part 892.1170
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

TBS Insight is a Densitometer, Bone (per OpenFDA classification), designed to evaluate bone microarchitecture using a standard lumbar spine DXA scan. It computes a Trabecular Bone Score (TBS) by analyzing the antero-posterior spine DXA examination file and compares the results to age-matched controls. The device provides a quantitative assessment of trabecular bone quality, complementing traditional DXA measurements to enhance diagnostic accuracy for osteoporosis and related conditions.

TBS Insight is supplied as software for use alongside DXA systems and is intended for single-use per scan analysis (no sterilization required). It operates in radiology settings and requires no special storage conditions beyond standard IT infrastructure. The device holds FDA 510(k) clearance (K121716) under the Radiology advisory committee, classified as Class II (OpenFDA). No MRI safety considerations apply, as it is a software-based solution. Multiple registration numbers (e.g., 3008921184) reflect its global distribution, but regulatory compliance is governed by the FDA’s 510(k) pathway as stated.

Similar devices

Other devices filed under FDA product code KGI (Densitometer, Bone).

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