FDA.reportPublic FDA data

DEXIS™ Software

Primary DI
EKAV101244750
Brand
DEXIS™ Software
Company
DEXIS LLC
Model
11
Catalog number
1.012.4475
Device description
Software
Published
2021-11-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, image processing, radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151941000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151941000DEXIS WebviewImaging Sciences International /Gendex/Dexis2015-10-07LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV101244750PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology information system application softwareAn application software program, routines, and/or algorithms used as or in a radiology information system (RIS) to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within/between facilites, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and work-list generation for specific radiological systems; it may be used in conjunction with PACS and include various technology imaging modalities. It is installed into a dedicated radiology information system or existing mainframe or decentralized computers/network.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18888833947support@dexis.com

Regulatory Flags#

DUNS number
019717844
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EKAV100879340DEXIS 10 (DEXIS Imaging Suite)101.008.79342022-01-21
EKAV101289030DEXcam3™ intraoral cameras1.012.89031.012.89032021-11-12
EKAV101289070DEXcam3™ intraoral cameras1.012.89071.012.89072021-11-12
EKAV082250710DEXIS Platinum™ intraoral sensor0.822.5071PLU5101S2016-09-24
EKAV082250730DEXIS Platinum™ intraoral sensor0.822.5073PLU5102C2016-09-24
EKAV082251940DEXIS Platinum™ intraoral sensor0.822.5194PLU6902016-09-24
EKAV100713330DEXcam3™ intraoral cameras1.007.1333PLU7902016-09-24
EKAV100719690DEXcam3™ intraoral cameras1.007.1969PLU7912016-09-24
EKAV100730420DEXIS Platinum™ intraoral sensor1.007.3042PLU5101I2016-09-24
EKAV100898740DEXIS Platinum™ intraoral sensor1.008.9874PLU690K2016-09-24
EKAV100898770DEXIS Platinum™ intraoral sensor1.008.9877PLU690R2016-09-24
EKAV101034080DEXIS™ Software9PLU2362017-04-14
EKAV101034090DEXIS™ Software9PLU2352017-04-14
EKAV101034110DEXIS™ Software9PLU3492017-04-14
EKAV101034120DEXIS™ Software9PLU2382017-04-14
EKAV101135330DEXIS™ Software11101244792016-12-19
EKAV101149840DEXcam4™ Intra-oral camera1.011.4984PLU7602016-09-24
EKAV101149960DEXcam4™ Intra-oral camera1.011.4996PLU7610K2016-09-24
EKAV101184170DEXIS Platinum™ intraoral sensor1.011.8417PLU5109S2016-09-24
EKAV101184180DEXIS Platinum™ intraoral sensor1.011.8418PLU5109C2016-09-24

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