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Artemis with ProFuse 2.0 HD

by Eigen Health Services LLC

Artemis with ProFuse 2.0 HD (900-20000-01) is a rectal ultrasound navigational image processor (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Eigen Health Services LLC, listed in FDA GUDID since 20 Dec 2024 (UDI-DI 00860009734838), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860009734838 UDI-DI Date20 Dec 2024ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Artemis with ProFuse
Generic name
Rectal ultrasound navigational image processor
Model / Ref / Catalog
2.0 HD, 900-20000-01
Primary DI / UDI-DI
00860009734838
FDA product code
LLZ
GMDN term
Rectal ultrasound navigational image processor
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rectal ultrasound navigational image processor

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Eigen Health Services LLC

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)