Standardize

GUDID 00860002304533

Standardize is software that provides standardized metadata descriptions of diagnostic medical images. It uses proprietary natural language processing (NLP) and computer vision (CV) algorithms to analyze DICOM image and metadata to identify key attributes of radiological examinations and series.

ENLITIC, INC.

Radiology DICOM image processing application software

• Primary Device ID: 00860002304533
• NIH Device Record Key: a5764ea7-8200-4dee-9e79-3de1545fc013
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standardize
• Version Model Number: 1.0.0
• 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	00860002304533 [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: 2022-02-28
• Device Publish Date: 2022-02-18

Devices Manufactured by ENLITIC, INC.

• 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: 2022-02-28Standardize is software that provides standardized metadata descriptions of diagnostic medical images. It uses proprietary natural language processing (NLP) and computer vision (CV) algorithms to analyze DICOM image and metadata to identify key attributes of radiological examinations and series.
• 00860002304533 - Standardize: 2022-02-28 Standardize is software that provides standardized metadata descriptions of diagnostic medical images. It uses proprietary natur