FDA.reportPublic FDA data

DEXIS™ Software

Primary DI
EKAV101034110
Brand
DEXIS™ Software
Company
DEXIS LLC
Model
9
Catalog number
PLU349
Device description
US & International
Published
2017-04-14
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
K090431000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090431000DEXIS SOFTWAREDexis, LLC2009-06-22LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV101034110PrimaryHIBCC0

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
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
EKAV101244750DEXIS™ Software111.012.44752021-11-12
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVLLZ2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001KF5I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L0LD0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L4120PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L7FI0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L9260PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000200F30PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000201K20PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000202L80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000203ID0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000205I00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0002066I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000207330PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000208K50PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0002098I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000209F30PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020D0F0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F080PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F670PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020I510PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20