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inHEART Models

by Inheart 2 variants

510(k) K231683

inHEART Models is a Class II device made by Inheart, cleared under FDA 510(k) K231683 on 29 Feb 2024, active as of 22 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 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 NumberK231683 Date29 Feb 2024ClearedStatusActive

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  • Withdrawn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
QIH
FDA applicant
Inheart, Sas
Device class
Class II
Regulation
21 CFR Part 892.2050
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

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

Devices cleared under K231683

5 devices · 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 K231683
UDI-DISize and differences
inHEART MODELS AI v1.1.0
INHEART
v1.1.003770019599075 —No longer on the market
inHEART MODELS AI v3
INHEART
v303770019599174 —On the market
inHEART MODELS Explorer v2.8.0
INHEART
v2.8.003770019599099 —No longer on the market
inHEART Models Explorer v3.0.0
INHEART
NA / v3.0.003770019599112 —On the market
inHEART MODELS Shaper v1.8.0
INHEART
v1.8.003770019599082 —On the market

Similar devices

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

Other devices from Inheart

See all devices from Inheart →