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Arterys MICA AMM7

by Arterys Inc.

Arterys MICA AMM7, a medical device (FDA Class II) made by Arterys Inc., was cleared under FDA 510(k) K203744 on 14 Mar 2022 and listed in FDA GUDID on 14 Nov 2022 (UDI-DI B664AMM70); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K203744

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 NumberB664AMM70 UDI-DI Date14 Nov 2022ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK203744 Date14 Mar 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203744 decided 14 Mar 2022 Active
  • FDA GUDID UDI-DI B664AMM70 listed 14 Nov 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K203744
  2. Listed FDA GUDID B664AMM70

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Arterys MICA
Generic name
Radiology DICOM image processing application software
Model / reference
AMM7
Primary DI / UDI-DI
B664AMM70
510(k) Number
FDA product code
QIH, LLZ
GMDN term
Radiology DICOM image processing application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
Not in Commercial Distribution

Similar devices

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

Other devices from Arterys Inc.

See all devices from Arterys Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)