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Heuron ICH

by Heuron Co., Ltd.

510(k) K233247

Heuron ICH is a medical device (FDA Class II; FDA product code QAS, Radiological Computer-Assisted Triage And Notification Software) made by Heuron Co., Ltd., cleared under FDA 510(k) K233247 on 15 May 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 NumberK233247 Date15 May 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  • Withdrawn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
QAS
Device class
Class II
Regulation
21 CFR Part 892.2080
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K233247

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 K233247
UDI-DISize and differences
Heuron ICH ST-ICT01
Heuron Co., Ltd.
ST-ICT0108800086200217 —On the market

Similar devices

Other devices filed under FDA product code QAS (Radiological Computer-Assisted Triage And Notification Software).

Other devices from Heuron Co., Ltd.

See all devices from Heuron Co., Ltd. →