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ElucidPlaqueIQ B.1P

by Elucid Bioimaging, Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB745ELUCIDB1P0 UDI-DIDate29 Oct 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  • Withdrawn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
ElucidPlaqueIQ
Generic Name
CT system application software
Model / Reference
B.1P
Primary DI / UDI-DI
B745ELUCIDB1P0
510(k) Number
FDA Product Code
LLZ
GMDN Term
CT system application software
Device Class
Class II
Regulation Number
892.2050
GUDID distribution status
In Commercial Distribution

Other devices from Elucid Bioimaging, Inc.

  • Elucid FFR-IQ (B.1)

    Class II

  • Elucid PlaqueIQ

    Class II

  • vascuCAP

    Class II

  • ElucidVivo A.3

    Class II

  • vascuCAP

    Class II

  • Elucid PlaqueIQ

    Class II

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No