Ust 5550-R

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Healthcare Americas Corporation

Identity

Trade Name: UST 5550-R FDA UDI
Generic Name: Surgical ultrasound imaging transducer FDA UDI
Device Name: Ultrasound Robotic Probe FDA UDI
Model / Reference: UST 5550-R FDA UDI
Description: Ultrasound Robotic Probe FDA UDI

Identifiers

Primary DI / UDI-DI: 00860007188312 FDA UDI
510(k) Number: K122537 FDA UDI
FDA Product Code: IYO FDA UDI
ITX FDA UDI
IYN FDA UDI
GMDN Term: Surgical ultrasound imaging transducer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1560 FDA UDI
892.1570 FDA UDI
892.1550 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

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

Sterilization Method

Hydrogen Peroxide FDA UDI

Category: Surgical ultrasound imaging transducer

Ust 5550-R by FUJIFILM Healthcare Americas Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical ultrasound imaging transducer.

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S31KP — FUJIFILM Corporation · Class II
I13C3f Transducer — Bk Medical ApS · Class II
C22T — FUJIFILM Corporation · Class II
UST-5418 — FUJIFILM Corporation · Class II
7LT4 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
HUMANSCAN — Humanscan Company, Ltd. · Class II

Cleared under the same submission

K122537 also covers:

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 Healthcare Americas Corporation

Sources (1)

FDA UDI ca7430a6-f277-4609-bea4-fbd82047cc88 34 fields · synced Jun 8, 2026