Basic Information
- Primary DI
- D-LT-MF-000022304EQ
- Basic UDI-DI Code
- B-LT-MF-000022304EQ
- Reference
- 1
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Oxipit, UAB
Additional Description
The ChestEye software is intended to support trained radiologists when reporting on chest X-ray images. The final report must be approved by a trained radiologist. The software is a fully automatic computer assisted diagnosis solution. Based on collected data (deep neural network) the software analyses a given chest X-ray image. By function, ChestEye consists of four parts: ChestEye CAD, ChestEye Queue, ChestEye Search and ChestEye Quality. Depending on the configuration, the result of the analysis is: โ A preliminary text report with detected pathologies optionally with heat maps representing location of each finding (ChestEye CAD) and a reporting priority/urgency level (ChestEye Queue); โ List of retrospective cases with similar radiological findings (ChestEye Search); โ Identification of potential reporting errors made by the reporting radiologists (ChestEye Quality).
CND Nomenclature Codes
| Code | Description |
|---|---|
| V92 | MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | HD 60135612 0001 | TรV Rheinland LGA Products GmbH | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).