ICTx/8-5 MHz

FDA UDIEUDAMED

Class II (US FDA UDI)

by Fujifilm Sonosite, Inc.

Identity

Trade Name: ICTx/8-5 MHz FDA UDI
Generic Name: Rectal/vaginal ultrasound imaging transducer FDA UDI
Device Name: Diagnostic Ultrasound Transducer FDA UDI
Model / Reference: P24312-04 FDA UDI
Description: Diagnostic Ultrasound Transducer FDA UDI

Identifiers

Primary DI / UDI-DI: 00841517106935 FDA UDI
FDA Product Code: ITX FDA UDI
IYN FDA UDI
IYO FDA UDI
GMDN Term: Rectal/vaginal ultrasound imaging transducer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
892.1550 FDA UDI
892.1560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Rectal/vaginal ultrasound imaging transducer

ICTx/8-5 MHz by Fujifilm Sonosite, Inc. — Class II — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Unknown
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Fujifilm Sonosite, Inc.

Sources (2)

FDA UDI a5ccadee-9ff1-477c-9415-f066ab35e71f 34 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 3, 2026