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Tempus Pixel AMM7

by Arterys Inc.

Tempus Pixel AMM7 is a medical device (FDA Class II) made by Arterys Inc., listed in FDA GUDID since 6 Mar 2025 (UDI-DI B664AMM71), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

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 NumberB664AMM71 UDI-DI Date6 Mar 2025ListedStatusListed GUDID: 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  • Withdrawn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
Tempus Pixel
Generic name
Radiology DICOM image processing application software
Model / reference
AMM7
Primary DI / UDI-DI
B664AMM71
FDA product code
QIH, LLZ
GMDN term
Radiology DICOM image processing application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

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Properties

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