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Heuron ICH ST-ICT01

by Heuron Co., Ltd.

Heuron ICH ST-ICT01 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 and listed in FDA GUDID since 24 Jun 2024 (UDI-DI 08800086200217), 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) K233247

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 Number08800086200217 UDI-DI Date24 Jun 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK233247 Date15 May 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K233247 decided 15 May 2024 Active
  • FDA GUDID UDI-DI 08800086200217 listed 24 Jun 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K233247
  2. Listed FDA GUDID 08800086200217

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Heuron ICH
Generic name
Radiology DICOM image processing application software
Model / reference
ST-ICT01
Primary DI / UDI-DI
08800086200217
510(k) Number
FDA product code
QAS
GMDN term
Radiology DICOM image processing application software
Device class
Class II
Regulation number
892.2080
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiology DICOM image processing application software

Similar devices in this category

Other devices filed under Radiology DICOM image processing application software.

Other devices from Heuron Co., Ltd.

See all devices from Heuron Co., Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)