Transducer S12BP4

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Healthcare Americas Corporation

Identity

Trade Name: Transducer S12BP4 FDA UDI
Generic Name: Surgical ultrasound imaging transducer FDA UDI
Device Name: Transducer S12BP4 – 11 mm Neurosurgery Probe FDA UDI
Model / Reference: S12BP4 FDA UDI
Description: Transducer S12BP4 – 11 mm Neurosurgery Probe FDA UDI

Identifiers

Primary DI / UDI-DI: 00860007188343 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

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

Sterilization Method

Hydrogen Peroxide FDA UDI

Category: Surgical ultrasound imaging transducer

Transducer S12BP4 by FUJIFILM Healthcare Americas Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Surgical ultrasound imaging transducer.

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UST-5418 — FUJIFILM Corporation · Class II
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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 39199406-95e7-438b-9888-1a4d62e18e56 34 fields · synced Jun 8, 2026