Ensight
Basic Information
- Brand Name
- Ensight
- Primary DI
- 00860002304557
- Version / Model
- 2.0
- Company Name
- Enlitic, Inc.
- Labeler DUNS
- 081152491
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-22
- Public Version
- 1
- Public Version Date
- 2024-05-30
- Public Version Status
- New
- Public Device Record Key
- 2a9b2cad-3c31-4c14-a20e-4fa804a73bdb
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | Radiology | 892.2020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57812 | Radiology DICOM image processing application software | A 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860002304557 | GS1 |