D²RS and D²RS 9090
Stephanix
Stephanix
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006972752 | 3006972752 | Stephanix | 1 | N | 2026-01-01 | 10 Rue Jean Moulin La Ricamarie Auvergne-Rhone-Alpes FR 42150 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 119385 | 1654489014 | K221335 | D²RS and D²RS 9090 | OWB | 2022-06-07 |
| 119385 | 1648667902 | K213479 | D²RS and D²RS 9090 | OWB | 2021-12-23 |
| 119385 | 1853613271 | K102529 | D2RF DIGITAL DYNAMIC REMOTE SYSTEM | OWB | 2010-10-07 |
| 119385 | 2049769878 | K090322 | EASY MOVING PLUS, SM-XXHF-YY | IZL | 2009-03-17 |
| 119385 | 1979761944 |
Product Codes Associated With Registrations#
PMN#
D²RS And D²RS 9090
Stephanix
MOVIX DReamy
Stephanix
D2RS_AT Digital Dynamic Remote System
STEPHANIX RADIOLOGICAL SOLUTIONS
D2RF DIGITAL DYNAMIC REMOTE SYSTEM
STEPHANIX RADIOLOGICAL SYSTEMS
GUDID#
STEPHANIX - 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.
2016-10-22
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
2016-10-22
STEPHANIX - MOVIX DReamy is a Digital Mobile Diagnostic X-Ray System equipped with the latest generation of Flat Panel Detector (FPD). Not for mammography.
2023-08-01
STEPHANIX - MOVIX DReamy is a Digital Mobile Diagnostic X-Ray System equipped with the latest generation of Flat Panel Detector (FPD). Not for mammography.
2023-08-01
STEPHANIX - MOVIX DReamy is a Digital Mobile Diagnostic X-Ray System equipped with the latest generation of Flat Panel Detector (FPD). Not for mammography.
2023-08-01
STEPHANIX - MOVIX DReamy is a Digital Mobile Diagnostic X-Ray System equipped with the latest generation of Flat Panel Detector (FPD). Not for mammography.
2023-08-01
STEPHANIX - 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. Not for mammography.
2023-06-05
STEPHANIX - 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. Not for mammography.
2023-06-05
STEPHANIX - 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. Not for mammography.
2023-06-05
STEPHANIX - 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. Not for mammography.
2023-06-05
STEPHANIX - 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. Not for mammography.
2023-06-05
STEPHANIX - 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. Not for mammography.
2023-06-05
STEPHANIX - 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. Not for mammography.
2023-06-05
STEPHANIX - 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. Not for mammography.
2023-06-05