MYRIAN

Primary DI

03700719700464

Brand

MYRIAN

Company

INTRASENSE

Model

MYRIAN 2.7.6

Device description

Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.

Published

2020-04-21

Public version status

Update

Distribution status

Not in Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information

Rx

true

OTC

false

Sterile

false

Single use

false