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Arterys MICA

by Arterys Inc. 3 variants

510(k) K192437

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 NumberK192437 Date25 Mar 2020ClearedStatusActive

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  • Withdrawn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
Arterys, Inc.
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

Cited by

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

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Arterys MICA is a cloud-based medical imaging analysis platform designed for radiologists and clinicians. It leverages artificial intelligence to process and analyze complex medical images from modalities such as CT and MRI, enhancing diagnostic capabilities with automated analytics and visualization tools.

Supplied as a web-based software solution, Arterys MICA is intended for use in clinical settings where radiologists and imaging specialists review diagnostic images. The platform is not a single-use or reusable physical device but a software application requiring internet connectivity and cloud infrastructure. It holds FDA 510(k) clearance under the product code QIH, with no explicit mention of sterility, MRI safety, or physical size specifications in the provided data.

Similar devices

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

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