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SmartChest V2.x.x

by Milvue

SmartChest V2.x.x is a Class II device made by Milvue, cleared under FDA 510(k) K232410 on 10 May 2024 and listed in FDA GUDID since 31 Mar 2025 (UDI-DI 03770024774016), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K232410

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03770024774016 UDI-DI Date31 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK232410 Date10 May 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K232410 decided 10 May 2024 Active
  • FDA GUDID UDI-DI 03770024774016 listed 31 Mar 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K232410
  2. Listed FDA GUDID 03770024774016

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SmartChest
Generic name
X-ray image interpretive software
Model / reference
V2.x.x
Primary DI / UDI-DI
03770024774016
510(k) Number
FDA product code
QFM
GMDN term
X-ray image interpretive software
Device class
Class II
Regulation number
892.2080
GUDID distribution status
In Commercial Distribution

Related devices

Category: X-ray image interpretive software

Similar devices

Other devices filed under FDA product code QFM (Radiological Computer-Assisted Prioritization Software For Lesions).

Other devices from Milvue

See all devices from Milvue →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)