L51K

GUDID 04573596212134

Probe

FUJIFILM HEALTHCARE CORPORATION

Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer

Primary Device ID	04573596212134
NIH Device Record Key	990e68c8-7aab-43f4-9e5c-7b27166fa299
Commercial Distribution Status	In Commercial Distribution
Brand Name	L51K
Version Model Number	L51K
Company DUNS	718262719
Company Name	FUJIFILM HEALTHCARE CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04562122958820 [Previous]
GS1	04573596212134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K163505

FDA Product Code

IYO	System, Imaging, Pulsed Echo, Ultrasonic