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Stephanix

Matched from indexed company URL: STEPHANIX

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30069727523006972752Stephanix1N2026-01-0110 Rue Jean Moulin La Ricamarie Auvergne-Rhone-Alpes FR 42150

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1193851654489014K221335D²RS and D²RS 9090OWB2022-06-07
1193851648667902K213479D²RS and D²RS 9090OWB2021-12-23
1193851853613271K102529D2RF DIGITAL DYNAMIC REMOTE SYSTEMOWB2010-10-07
1193852049769878K090322EASY MOVING PLUS, SM-XXHF-YYIZL2009-03-17
1193851979761944

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OWB32022-06-07
IZL12009-03-17

PMN#

GUDID#

STEPHANIX - 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

STEPHANIX

2016-10-22