FDA.reportPublic FDA data

DEXIS 10 (DEXIS Imaging Suite)

Primary DI
D090100879340
Brand
DEXIS 10 (DEXIS Imaging Suite)
Company
Dental Imaging Technologies Corporation
Model
1.008.7934
Published
2024-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
D090100879340PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
800111106
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00693856000340DEXIS Imprevo SLIM TIPDEXIS Imprevo59456602026-08-07
D090101399140DEXIS IXS Size 2 Accessory Layer1.013.99142026-08-03
D090101399150DEXIS IXS Size 2 Accessory Layer1.013.99152026-08-03
D090101399160DEXIS IXS Size 2 Accessory Layer1.013.99162026-08-03
D090101399170DEXIS IXS Size 1 Accessory Layer1.013.99172026-08-03
D090101399180DEXIS IXS Size 1 Accessory Layer1.013.99182026-08-03
D090101399190DEXIS IXS Size 1 Accessory Layer1.013.99192026-08-03
D090101461070DEXIS IXS Size 1 Accessory Layer1.014.61072026-08-03
D090101461090DEXIS IXS Size 2 Accessory Layer1.013.29162026-08-03
D090101461480DEXIS Titanium Accessory Layer1.014.61482026-08-03
D090101461490DEXIS Titanium Accessory Layer1.014.61492026-08-03
D090101461500DEXIS Titanium Accessory Layer1.014.61502026-08-03
D090101461510DEXIS Titanium Accessory Layer1.014.61512026-08-03
D090101461520DEXIS Titanium Accessory Layer1.014.61522026-08-03
D090101397120IXS S2 Kit, CT, US, FR-CA1.013.97122026-05-12
00693856000203Assembly-IS 3700 SIDE TIPIS 3700TA08502025-12-04
00693856000227Assembly-IS 3700 POSTERIOR TIPIS 3700TA08602025-12-04
D090101329460DEXIS IXS Size 1 Sensor - R1.013.29461.013.29462026-04-01
D090101329470DEXIS IXS Size 2 Sensor - R1.013.29471.013.29472026-04-01
D090800045720DEXIS Ti2 Sensor - R - S8.000.45728.000.45722026-04-01

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