Fujifilm

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name: FUJIFILM FDA UDI
Generic Name: Surgical ultrasound imaging transducer FDA UDI
Device Name: This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree under the management of physicians at medical facilities. Modes of Operation: B-mode Never use this product for any other purposes FDA UDI
Model / Reference: PB2020-M2 FDA UDI
Description: This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree under the management of physicians at medical facilities. Modes of Operation: B-mode Never use this product for any other purposes FDA UDI

Identifiers

Primary DI / UDI-DI: 04547410445886 FDA UDI
510(k) Number: K214089 FDA UDI
FDA Product Code: IYO FDA UDI
ODG FDA UDI
ITX FDA UDI
GMDN Term: Surgical ultrasound imaging transducer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1560 FDA UDI
876.1500 FDA UDI
892.1570 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

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Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

Yes

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Manufacturing Date

Yes

FDA UDI

Category: Surgical ultrasound imaging transducer

Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K214089 also covers:

FUJIFILM — FUJIFILM Corporation

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: FUJIFILM Corporation

Sources (1)

FDA UDI b2e521f8-749d-42d9-bb3e-21aae20ced71 36 fields · synced May 30, 2026