| Primary Device ID | 00860002304526 |
| NIH Device Record Key | 6b6e1c7a-42db-4906-ada0-2abc9c733a12 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enlitic Curie |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00860002304526 [Primary] |
| LMD | System, Digital Image Communications, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-28 |
| Device Publish Date | 2022-02-18 |
| 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 | 2022-02-28Enlitic Curie is a software platform for products and related components developed by Enlitic. The platform includes user management, DICOM archive, settings, auditing, and a landing page. It also allows for integrations with other devices such as third-party PACS. |
| 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ENLITIC CURIE 88786270 not registered Live/Pending |
Enlitic, Inc. 2020-02-05 |