Ensight

Primary DI
00860002304557
Brand
Ensight
Company
Enlitic, Inc.
Model
2.0
Device description
Software that generates standardized metadata descriptions of medical images. The software also de-identifies PHI in metadata and image pixel data of medical images. The output of this functionality is used for various healthcare workflows such as hanging protocols, billing, and research. Using proprietary natural language processing (NLP) and computer vision (CV) algorithms, it reviews information from DICOM images and metadata to identify key attributes of radiological examinations for standardization, and for detecting and redacting PHI. It contains basic functionality such as user access and security, dashboards for analytics, and allows for integration with other devices such as third-party PACS software.Ensight does not aid in any diagnosis or provide any diagnostic information.
Published
2024-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002304557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002304557008600023045578600023045570860002304557

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081152491
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860002304540Curie ENDEX1.0.02022-08-31
00860002304526Enlitic Curie1.0.02022-02-18
00860002304533Standardize1.0.02022-02-18

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