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ICTx/8-5 MHz

by Fujifilm Sonosite, Inc. 14 variants

Ref P07690-81AModel TRANSDUCER, ICTX/8-5 MHZ

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08415171ICTXJW Basic UDI-DI 00841517106232UDI-DIDate28 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00841517106232 UDI-DI Date13 Oct 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

    • Terminated Z-0027-2014 FDA Class II initiated 11 Sep 2013 on shared 510(k) K130173

    FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Rectal/vaginal ultrasound imaging transducer
Device Name
Transducer, Ictx/8-5 Mhz
Model / Ref / Catalog
TRANSDUCER, ICTX/8-5 MHZ, P07690-81A, P07690
Primary DI / UDI-DI
00841517106232
Basic UDI-DI
08415171ICTXJW
510(k) Number
FDA Product Code
ITX
EMDN Code
Z110402010201 Curvilinear transcutaneous two–dimensional ultrasound probes (convex–array)
GMDN Term
Rectal/vaginal ultrasound imaging transducer
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1570
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000001075
Authorised representative
Fujifilm Sonosite B.V. NL-AR-000000046

Related devices

Category: Extracorporeal ultrasound imaging transducer, hand-held

Other devices from Fujifilm Sonosite, Inc.

See all devices from Fujifilm Sonosite, Inc. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No