Ust-5550

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

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

Identifiers

Primary DI / UDI-DI: 04573596212936 FDA UDI
510(k) Number: K043196 FDA UDI
K093488 FDA UDI
K122341 FDA UDI
K122537 FDA UDI
K134016 FDA UDI
K140443 FDA UDI
FDA Product Code: IYO FDA UDI
IYN 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
892.1550 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical ultrasound imaging transducer

Ust-5550 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

Cleared under the same submission

K043196 also covers:

MP-2456 — FUJIFILM Corporation

K093488 also covers:

K122341 also covers:

K122537 also covers:

K134016 also covers:

ARIETTA 70 — FUJIFILM Corporation
C22I — FUJIFILM Corporation
C22T — FUJIFILM Corporation
L46K — FUJIFILM Corporation
S12 — FUJIFILM Corporation
S22 — FUJIFILM Corporation
S31KP — FUJIFILM Corporation
VL54 — FUJIFILM Corporation
C9150LA — FUJIFILM Healthcare Americas Corporation

K140443 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

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

Manufacturer

Manufacturer: FUJIFILM Corporation

Sources (1)

FDA UDI 308f720c-c2eb-40fc-8938-a5bb0535a943 35 fields · synced May 30, 2026