ENLITIC, INC.

Address:3420 E Harmony Rd. Suite 125,Fort Collins,CO,80528,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Digital Image Communications, Radiological (LMD) (3)

Premarket Exempt

Yes

Clear

Enlitic Curie - 00860002304526 Catalog Number :

Device Description : The Curie product is a software platform that hosts applications related to vari The Curie product is a software platform that hosts applications related to various healthcare workflows, contains basic functionality such as user access and security, and allows for integrations with other devices such as third-party PACs systems.

Device Class : 1

Duns Number: 081152491

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : Yes

Device Count : 1

Standardize - 00860002304533 Catalog Number :

Device Description : Standardize is software that provides standardized metadata descriptions of diag Standardize is software that provides standardized metadata descriptions of diagnostic medical images. It uses proprietary natural language processing and computer vision algorithms to analyze DICOM images and metadata to identify key attributes of radiological examinations and series.

Device Class : 1

Duns Number: 081152491

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : Yes

Device Count : 1

Curie ENDEX - 00860002304540 Catalog Number :

Device Description : Software that provides standardized metadata descriptions of diagnostic medical Software that provides standardized metadata descriptions of diagnostic medical images. It uses proprietary natural language processing and computer vision algorithms to analyze DICOM images and metadata to identify key attributes of radiological examinations and series.

Device Class : 1

Duns Number: 081152491

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : Yes

Device Count : 1

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