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inHEART MODELS AI v3

by Inheart

inHEART MODELS AI v3 is a Class II device made by Inheart, cleared under FDA 510(k) K231683 on 29 Feb 2024 and listed in FDA GUDID since 19 Jun 2026 (UDI-DI 03770019599174), 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) K231683

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 Number03770019599174 UDI-DI Date19 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK231683 Date29 Feb 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231683 decided 29 Feb 2024 Active
  • FDA GUDID UDI-DI 03770019599174 listed 19 Jun 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K231683
  2. Listed FDA GUDID 03770019599174

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
inHEART MODELS AI
Generic name
Image segmentation application software
Model / reference
v3
Primary DI / UDI-DI
03770019599174
510(k) Number
FDA product code
QIH, LLZ
GMDN term
Image segmentation application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K231683)

Similar devices

Other devices filed under FDA product code QIH (Automated Radiological Image Processing Software).

Other devices from Inheart

See all devices from Inheart →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)