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Fujifilm CC13HPB5

by FUJIFILM Healthcare Americas Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

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 Number00860007188367 UDI-DI Date29 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0189-2022 FDA Class II initiated 14 Oct 2021

    Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Fujifilm
Generic Name
Surgical ultrasound imaging transducer
Model / Reference
CC13HPB5
Primary DI / UDI-DI
00860007188367
510(k) Number
FDA Product Code
IYN, ITX, IYO
GMDN Term
Surgical ultrasound imaging transducer
Device Class
Class II
Regulation Number
892.1550, 892.1570, 892.1560
GUDID distribution status
In Commercial Distribution
Sterilization Method
Hydrogen Peroxide

Related devices

Cleared under the same submission (K191233)

Other devices from FUJIFILM Healthcare Americas Corporation

See all devices from FUJIFILM Healthcare Americas Corporation →

Properties

  • Prescription Use
  • Serial 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
  • Lot / Batch Number: No
  • Expiration Date: No