STEPHANIX

Address:10 Rue Jean Moulin,La Ricamarie Auvergne-Rhone-Alpes,FR

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, X-Ray, Fluoroscopic, Image-Intensified (JAA) (2)

Premarket Exempt

Clear

STEPHANIX - 03664049000017 Catalog Number :

Device Description : D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography s D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections. Not for mammography.

Device Class : 2

Duns Number: 381826536

Premarket Exempt : No

Product Code : JAA

Prescription Use : Yes

Device Count : 1

STEPHANIX - 03664049000024 Catalog Number :

Device Description : The D2RS_AT Digital Dynamic Remote System is a direct digital dynamic remote-con The D2RS_AT Digital Dynamic Remote System is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Trixell Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections to create a unique and highly versatile 3-in-1 imaging solution. The receptor panel directly converts the X-ray images captured by the sensor into a high-resolution digital images. The instrument is suited for use inside a patient environment. Not for mammography