Eu Mdd Eu Md Class 2a On The Market ๐Ÿ‡ฑ๐Ÿ‡น Lithuania

ChestEye

Oxipit, UAB ยท ๐Ÿ‡ฑ๐Ÿ‡น Lithuania
Devices (same UDI-DI)
1
Certificates
1
Countries
7
Notified Bodies
1

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
MDD Annex II (excluding section 4) HD 60135612 0001

Available In Countries

๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ต๐Ÿ‡ฑ Poland

Similar Devices

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).

View all