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
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
D090800045730DEXIS IXS Size 1 Sensor - S8.000.45738.000.45732026-04-01
D090800045740DEXIS IXS Size 1 Sensor - R - S8.000.45748.000.45742026-04-01
D090800045750DEXIS IXS Size 2 Sensor - S8.000.45758.000.45752026-04-01
D090800045760DEXIS IXS Size 2 Sensor - R - S8.000.45768.000.45762026-04-01
D090800045770DEXIS Ti2 Kit - S8.000.45778.000.45772026-04-01
D090800045780DEXIS IXS Size 2 Sensor - D8.000.49788.000.49782026-04-01
D090800045790DEXIS IXS S1 Kit8.000.45798.000.45792026-04-01
D090800045810DEXIS IXS S2 Kit8.000.45818.000.45812026-04-01
D090800045830DEXIS Ti2 Kit - S8.000.45838.000.45832026-04-01
D090800045840DEXIS Ti2 Kit - R - S8.000.45848.000.45842026-04-01
D090800045850IXS S1 Warranty Replacement - S8.000.45858.000.45852026-04-01
D090800045860IXS S1 Warranty Replacement Kit8.000.45868.000.45862026-04-01
D090800045870IXS S2 Warranty NEW Kit8.000.45878.000.45872026-04-01
D090800045880IXS S2 Warranty Replacement Kit8.000.45888.000.45882026-04-01

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Primary DI, Brand, Company table
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08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
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EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
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08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
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