OBView

GUDID 00857050006014

System, Image Processing, Radiological - Doctors reading Station

Digisonics Inc

Radiology PACS software
Primary Device ID00857050006014
NIH Device Record Key9b4bb2e2-25d1-41c3-9258-0ae6e5c470b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameOBView
Version Model Number4.8
Company DUNS099807927
Company NameDigisonics Inc
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 Numberfalse
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
GS100857050006014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-27
Device Publish Date2020-07-17

On-Brand Devices [OBView]

00857050006014System, Image Processing, Radiological - Doctors reading Station
00857050006021System, Image Processing, Radiological - Doctors Reading Station

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