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, airways and tracheobronchial tree under the management of physicians at medical facilities. FDA UDI
Model / Reference: PB2020-M FDA UDI
Description: This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract, airways and tracheobronchial tree under the management of physicians at medical facilities. FDA UDI

Identifiers

Primary DI / UDI-DI: 04547410343052 FDA UDI
510(k) Number: K171207 FDA UDI
FDA Product Code: ITX FDA UDI
ODG FDA UDI
IYO FDA UDI
GMDN Term: Surgical ultrasound imaging transducer FDA UDI

Classification

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

FDA UDI

Category: Surgical ultrasound imaging transducer

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

Similar devices

Also classified as Surgical ultrasound imaging transducer.

HUMANSCAN — Humanscan Company, Ltd. · Class II
I13C3f Transducer — Bk Medical ApS · Class II
7LT4 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
HUMANSCAN — Humanscan Company, Ltd. · Class II
C9150LA — FUJIFILM Healthcare Americas Corporation · Class II
I14C5I Transducer — Bk Medical ApS · Class II
SonoScape — SONOSCAPE MEDICAL CORP. · Class II
N13C5 Transducer — Bk Medical ApS · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: FUJIFILM Corporation

Sources (1)

FDA UDI 78dffc7b-4a2b-4611-8b2b-232188573bdc 36 fields · synced May 30, 2026