Dolphin/XF Robot Accessory

GUDID 07290016880229

The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cerebral blood flow velocity

VIASONIX LTD

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system
Primary Device ID07290016880229
NIH Device Record Keyd9e0e5ac-7e52-4246-a2e6-ff04c2d57cab
Commercial Distribution Discontinuation2021-03-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDolphin/XF Robot Accessory
Version Model NumberDolphin/XF Robot Accessory
Company DUNS533070236
Company NameVIASONIX LTD
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016880229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31

Devices Manufactured by VIASONIX LTD

07290016880229 - Dolphin/XF Robot Accessory2021-04-08The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cerebral blood flow velocity
07290016880229 - Dolphin/XF Robot Accessory2021-04-08 The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cere
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07290016880274 - LiteWalk Sandals2020-06-29 The LiteWalk pneumatic sandals [left/right] include 4 inflatable chambers that are located in the general regions of the heel, a

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