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Hitachi Healthcare Americas

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Healthcare Americas Corporation

Identity

Trade Name
HITACHI HEALTHCARE AMERICAS FDA UDI
Generic Name
Surgical ultrasound imaging transducer FDA UDI
Device Name
Ultrasound transducer FDA UDI
Model / Reference
C9150LA FDA UDI
Description
Ultrasound transducer FDA UDI

Identifiers

Primary DI / UDI-DI
00869047000448 FDA UDI
510(k) Number
K134016 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
Not 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

No

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
Sterilization Method
Hydrogen Peroxide FDA UDI

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

Cleared under the same submission

K134016 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FUJIFILM Healthcare Americas Corporation

Sources (1)

  • FDA UDI 901a0333-0aa1-4fdc-aeaa-4cacfe9f9e44 35 fields · synced Jun 8, 2026