cvi42

GUDID 00882916000028

Circle Cardiovascular Imaging Inc

MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software
Primary Device ID00882916000028
NIH Device Record Key29304589-d56a-4b9e-8bce-5e7f511743c2
Commercial Distribution StatusIn Commercial Distribution
Brand Namecvi42
Version Model Number6.x
Company DUNS248028578
Company NameCircle Cardiovascular Imaging 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 Numbertrue
Manufacturing Datefalse
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
GS100882916000028 [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 Date2024-01-23
Device Publish Date2024-01-15

On-Brand Devices [cvi42]

00088291600001Cardiac MR & CT imaging software application
008829160000115.x
00882916000004Cardiac MR & CT imaging software application
008829160000286.x
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