C9150LA

GUDID 00860007188305

4-way Laparoscopic Ultrasound Transducer/Smart Connector

HITACHI HEALTHCARE AMERICAS CORPORATION

Surgical ultrasound imaging transducer
Primary Device ID00860007188305
NIH Device Record Keya11b1910-ba5a-4572-8692-91262ce2c12e
Commercial Distribution StatusIn Commercial Distribution
Brand NameC9150LA
Version Model NumberC9150LA
Company DUNS603156043
Company NameHITACHI HEALTHCARE AMERICAS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860007188305 [Primary]
GS100869047000448 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


[00860007188305]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-09
Device Publish Date2021-07-01

Devices Manufactured by HITACHI HEALTHCARE AMERICAS CORPORATION

00860007188305 - C9150LA2021-07-094-way Laparoscopic Ultrasound Transducer/Smart Connector
00860007188305 - C9150LA2021-07-09 4-way Laparoscopic Ultrasound Transducer/Smart Connector
00860007188312 - UST 5550-R2021-07-09 Ultrasound Robotic Probe
00860007188329 - UST-91502021-07-09 Ultrasound Laparoscopic Probe
00860007188336 - UST-52114P-B2021-07-09 Ultrasound Brainpath Probe
00869047000455 - D&K Technologies2021-02-23 System Arm, Stabilizer, Stepper & Stand
00869047000462 - D&K Technologies2021-02-23 System Arm, Stabilizer, Stepper & Stand
00869047000448 - HITACHI HEALTHCARE AMERICAS2020-07-07 Ultrasound transducer
00869047000431 - VidiStar PACS & DICOM Viewer Software2019-05-23 The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as

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