Skip to content

TechCare Trauma

by Milvue

510(k) K242171

TechCare Trauma is a Class II device made by Milvue, cleared under FDA 510(k) K242171 on 17 Jan 2025, active as of 11 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK242171 Date17 Jan 2025ClearedStatusActive

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  • Withdrawn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
QBS
Device class
Class II
Regulation
21 CFR Part 892.2090
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K242171

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K242171
UDI-DISize and differences
TechCare Trauma V1.1.x
MILVUE
V1.1.x03770024774047 —On the market

Similar devices

Other devices filed under FDA product code QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture).

Other devices from Milvue

See all devices from Milvue →