DEXIS 10 (DEXIS Imaging Suite) 1.008.7934

GUDID EKAV100879340

DEXIS LLC

Radiology information system application software
Primary Device IDEKAV100879340
NIH Device Record Key2833d196-ac29-44a1-9768-90dfc50fa217
Commercial Distribution StatusIn Commercial Distribution
Brand NameDEXIS 10 (DEXIS Imaging Suite)
Version Model Number10
Catalog Number1.008.7934
Company DUNS019717844
Company NameDEXIS LLC
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
HIBCCEKAV100879340 [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 Date2022-01-31
Device Publish Date2022-01-21

Devices Manufactured by DEXIS LLC

EKAV100879340 - DEXIS 10 (DEXIS Imaging Suite)2022-01-31
EKAV100879340 - DEXIS 10 (DEXIS Imaging Suite)2022-01-31
EKAV101244750 - DEXIS™ Software2021-11-22 Software
EKAV101289030 - DEXcam3™ intraoral cameras2021-11-22 Digital intraoral camera
EKAV101289070 - DEXcam3™ intraoral cameras2021-11-22 Digital intraoral camera
EKAV082250710 - DEXIS Platinum™ intraoral sensor2018-07-06 Digital intraoral sensor
EKAV082250730 - DEXIS Platinum™ intraoral sensor2018-07-06 Digital intraoral sensor
EKAV082250740 - DEXIS Platinum™ intraoral sensor2018-07-06 Digital intraoral sensor
EKAV082251940 - DEXIS Platinum™ intraoral sensor2018-07-06 Digital intraoral sensor

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