L46k

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name: L46K FDA UDI
Generic Name: Surgical ultrasound imaging transducer FDA UDI
Device Name: Probe FDA UDI
Model / Reference: L46K FDA UDI
Description: Probe FDA UDI

Identifiers

Primary DI / UDI-DI: 04573596212110 FDA UDI
510(k) Number: 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

L46k by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

K134016 also covers:

ARIETTA 70 — FUJIFILM Corporation
C22I — FUJIFILM Corporation
C22T — FUJIFILM Corporation
S12 — FUJIFILM Corporation
S22 — FUJIFILM Corporation
S31KP — FUJIFILM Corporation
UST-5550 — 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

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Manufacturer

Manufacturer: FUJIFILM Corporation

Sources (1)

FDA UDI 6e1cf96e-6e54-439f-a7c9-8069078c24d7 35 fields · synced May 30, 2026