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Arterys MICA AMM5

by Arterys Inc.

Arterys MICA AMM5, a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Arterys Inc., was listed in FDA GUDID on 25 Jun 2019 (UDI-DI B664AMM50); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB664AMM50 UDI-DI Date25 Jun 2019ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Arterys MICA
Generic name
Radiology DICOM image processing application software
Model / reference
AMM5
Primary DI / UDI-DI
B664AMM50
FDA product code
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 LLZ (System, Image Processing, Radiological).

Other devices from Arterys Inc.

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Properties

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