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Hepatica 1.0.0

by Perspectum

Hepatica 1.0.0 is a Class II device made by Perspectum, listed in FDA GUDID since 12 Feb 2021 (UDI-DI B554HEPATICA100), 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 NumberB554HEPATICA100 UDI-DI Date12 Feb 2021ListedStatusListed 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  • Withdrawn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
Hepatica
Generic name
Radiology DICOM image processing application software
Model / reference
1.0.0
Primary DI / UDI-DI
B554HEPATICA100
FDA product code
LNH
GMDN term
Radiology DICOM image processing application software
Device class
Class II
Regulation number
892.1000
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiology DICOM image processing application software

Similar devices in this category

Other devices filed under Radiology DICOM image processing application software.

Other devices from Perspectum

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Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)