Ensight

GUDID 00860002304557

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.

Enlitic, Inc.

Radiology DICOM image processing application software

• Primary Device ID: 00860002304557
• NIH Device Record Key: 2a9b2cad-3c31-4c14-a20e-4fa804a73bdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ensight
• Version Model Number: 2.0
• Company DUNS: 081152491
• Company Name: Enlitic, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002304557 [Primary]

FDA Product Code

• LMD: System, Digital Image Communications, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-30
• Device Publish Date: 2024-05-22

Devices Manufactured by Enlitic, Inc.

• 00860002304557 - Ensight: 2024-05-30Software 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.
• 00860002304557 - Ensight: 2024-05-30 Software that generates standardized metadata descriptions of medical images. The software also de-identifies PHI in metadata an
• 00860002304540 - Curie|ENDEX: 2022-09-08 Software that provides standardized metadata descriptions of diagnostic medical images. It uses proprietary natural language pro
• 00860002304526 - Enlitic Curie: 2022-02-28 Enlitic Curie is a software platform for products and related components developed by Enlitic. The platform includes user manage
• 00860002304533 - Standardize: 2022-02-28 Standardize is software that provides standardized metadata descriptions of diagnostic medical images. It uses proprietary natur