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HealthICH

by Zebra Medical Vision, Ltd. 510(k)

Active United States

510(k) K190424

Overview

HealthICH is a Radiological Computer-Assisted Triage and Notification Software designed to assist radiologists in the detection and triage of intracranial hemorrhage (ICH) using machine learning algorithms. It operates as a diagnostic aid to enhance workflow efficiency and improve diagnostic accuracy by flagging potential abnormalities in imaging studies.

The device is supplied as a software solution, intended for use in radiology departments within healthcare facilities. It is classified as a Class II medical device under FDA regulations (892.2080) and requires no sterility or single-use considerations. HealthICH is authorized for use in the United States following FDA 510(k) clearance (K190424) under the Radiology advisory committee, with no third-party involvement in the submission process.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK190424 Date13 Jun 2019ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

Other devices from Zebra Medical Vision, Ltd.

  • HealthCCS

    Class II

  • HealthPNX

    Class II

  • HealthCXR

    Class II

  • HealthCCSng

    Class II

  • HealthJOINT

    Class II

  • HealthPPT

    Class II

See all devices from Zebra Medical Vision, Ltd. →

Questions

  • What is the primary purpose of HealthICH in a radiology workflow?

    HealthICH is designed as a diagnostic aid to assist radiologists in detecting and triaging intracranial hemorrhages (ICH) more efficiently. It uses machine learning algorithms to analyze imaging studies and flag potential abnormalities, helping to streamline workflow and improve diagnostic accuracy without replacing the radiologist’s final interpretation.

  • How is HealthICH supplied, and are there any sterility or single-use requirements?

    HealthICH is supplied exclusively as a software solution for installation in radiology departments. Since it is a digital tool with no physical components, there are no sterility requirements or single-use constraints—it can be reused across multiple imaging studies and facilities.

  • What regulatory pathway was followed for FDA clearance, and who submitted the application?

    HealthICH received FDA 510(k) clearance (K190424) under the Radiology advisory committee (RA) via a traditional review process. The submission was filed directly by Zebra Medical Vision, Ltd. without third-party involvement, and the device was classified as substantially equivalent to a predicate under FDA regulations (892.2080).

  • Can HealthICH be used with any imaging modality, or is it limited to specific types?

    While the device data does not specify modalities, HealthICH is explicitly designed for radiological imaging studies to detect intracranial hemorrhage. It is intended for use with standard imaging equipment in radiology departments, though compatibility should be confirmed with your facility’s existing systems before integration.