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Ust-5413

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name
UST-5413 FDA UDI
Generic Name
Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Device Name
Probe FDA UDI
Model / Reference
UST-5413 FDA UDI
Description
Probe FDA UDI

Identifiers

Primary DI / UDI-DI
04573596212769 FDA UDI
510(k) Number
K080176 FDA UDI
K093488 FDA UDI
K111227 FDA UDI
K122341 FDA UDI
FDA Product Code
IYO FDA UDI
IYN FDA UDI
ITX FDA UDI
GMDN Term
Extracorporeal ultrasound imaging transducer, hand-held 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Extracorporeal ultrasound imaging transducer, hand-held

Ust-5413 by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extracorporeal ultrasound imaging transducer, hand-held.

Cleared under the same submission

K080176 also covers:

K093488 also covers:

K111227 also covers:

K122341 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FUJIFILM Corporation

Sources (1)

  • FDA UDI b0606c9c-a920-4cb6-8816-a1d8abb09049 35 fields · synced May 30, 2026