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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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FDR D-EVO G43s - 04547410235975

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 602 SE WIRED A E
In Commercial Distribution

  • 04547410235975 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO G43i - 04547410235968

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 602 SE A E
In Commercial Distribution

  • 04547410235968 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO G35s - 04547410235951

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 601 SE WIRED A E
In Commercial Distribution

  • 04547410235951 ()

  • 460x384x14.8mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO G35i - 04547410235944

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 601 SE A E
In Commercial Distribution

  • 04547410235944 ()

  • 460x384x14.8mm


  • Stationary basic diagnostic x-ray system, digital

DR-ID 600MC - 04547410235937

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 601 MC-WITHOUT SOFT E
In Commercial Distribution

  • 04547410235937 ()


  • Stationary basic diagnostic x-ray system, digital

Cradle - 04547410235920

The Cradle for 24 is used for storing the flat panel sensor in a standing position. By using in combination with the CALNEO C power supply unit or the AC adapter for cradle (optional), the battery pack for the fl at panel sensor inserted into the Cradle for 24 can be charged. In addition, when the Cradle for 24 is connected to the CALNEO C power supply unit, the wireless communication setting can be switched.
FUJIFILM CORPORATION
DR613 STAND E
In Commercial Distribution

  • 04547410235920 ()


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO plus C24s - 04547410225587

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 613 SE WIRED E
In Commercial Distribution

  • 04547410225587 ()

  • 328x268x15.7mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO plus C24i - 04547410225570

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 613 SE E
In Commercial Distribution

  • 04547410225570 ()

  • 328x268x15.7mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO plus C35i - 04547410196863

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 611 SE E
In Commercial Distribution

  • 04547410196863 ()

  • 460x384x15.5mm


  • Stationary basic diagnostic x-ray system, digital

DR-ID 600MC - 04547410134551

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 600 MC E
In Commercial Distribution

  • 04547410134551 ()


  • Stationary basic diagnostic x-ray system, digital

DRX-Compass X-ray System - 60889978624768

XRAY OTC 80KW 400KHU AUTOTILT CF OSHPD
CARESTREAM HEALTH, INC.
DRX-Compass X-ray System
In Commercial Distribution

  • 60889978624768 ()
8624769

  • Stationary basic diagnostic x-ray system, digital

DRX-Compass X-ray System - 60889978624744

X-RAY FMT SYSTEM ANALOG CONSOLE PDU C/F
CARESTREAM HEALTH, INC.
DRX-Compass X-ray System
In Commercial Distribution

  • 60889978624744 ()
8624744

  • Stationary basic diagnostic x-ray system, digital

DRX-Compass X-ray System - 60889978624737

X-RAY FMT SYSTEM DIGITAL CONSOLE PDU C/F
CARESTREAM HEALTH, INC.
DRX-Compass X-ray System
In Commercial Distribution

  • 60889978624737 ()
8624736

  • Stationary basic diagnostic x-ray system, digital

CARESTREAM DRX-EVOLUTION Plus - 60889978624263

DRX-EVOLUTION PLUS SYSTEM LOSHPD
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION Plus
In Commercial Distribution

  • 60889978624263 ()
8624264

  • Stationary basic diagnostic x-ray system, digital

CARESTREAM DRX-EVOLUTION Plus - 60889978624256

DRX-EVOLUTION PLUS SYSTEM L1741040
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION Plus
In Commercial Distribution

  • 60889978624256 ()
8624256

  • Stationary basic diagnostic x-ray system, digital

CARESTREAM DRX-EVOLUTION Plus - 60889978624249

DRX-EVOLUTION PLUS SYSTEM L1741032
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION Plus
In Commercial Distribution

  • 60889978624249 ()
8624249

  • Stationary basic diagnostic x-ray system, digital

CARESTREAM DRX-EVOLUTION Plus - 60889978624218

DRX-EVOLUTION PLUS SYSTEM L1739218
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION Plus
In Commercial Distribution

  • 60889978624218 ()
8624215

  • Stationary basic diagnostic x-ray system, digital

CARESTREAM DRX-EVOLUTION Plus - 60889978624201

DRX-EVOLUTION PLUS SYSTEM L1739192
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION Plus
In Commercial Distribution

  • 60889978624201 ()
8624207

  • Stationary basic diagnostic x-ray system, digital

DRX-Compass X-ray System - 60889978624195

X-RAY SYSTEM CONSOLE PDU 3 P 208-240 C/F
CARESTREAM HEALTH, INC.
DRX-Compass X-ray System
In Commercial Distribution

  • 60889978624195 ()
8624199

  • Stationary basic diagnostic x-ray system, digital

DRX-Compass X-ray System - 60889978624188

X-RAY SYSTEM CONSOLE PDU 3 P 380-480 C/F
CARESTREAM HEALTH, INC.
DRX-Compass X-ray System
In Commercial Distribution

  • 60889978624188 ()
8624181

  • Stationary basic diagnostic x-ray system, digital

NONE - 60889978622351

X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F
CARESTREAM HEALTH, INC.
NONE
In Commercial Distribution

  • 60889978622351 ()
8622359

  • Stationary basic diagnostic x-ray system, digital

Value Systems - 60889978621668

GENERATOR GRP D 50KW 3P 208-240 VAC
CARESTREAM HEALTH, INC.
Value Systems
In Commercial Distribution

  • 60889978621668 ()
8621666

  • Stationary basic diagnostic x-ray system, digital

Value Systems - 60889978621651

GENERATOR GRP C 50KW 3P 380-480 VAC
CARESTREAM HEALTH, INC.
Value Systems
In Commercial Distribution

  • 60889978621651 ()
8621658

  • Stationary basic diagnostic x-ray system, digital

DRX-COMPASS X-RAY SYSTEM - 60889978621613

X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F
CARESTREAM HEALTH, INC.
DRX-COMPASS X-RAY SYSTEM
In Commercial Distribution

  • 60889978621613 ()
8621617

  • Stationary basic diagnostic x-ray system, digital

DRX-Evolution Plus System - 60889978602773

FIBRE GRID DRX-EVO WALL 180CM10:1 40LPCM
CARESTREAM HEALTH, INC.
DRX-Evolution Plus System
In Commercial Distribution

  • 60889978602773 ()
8602773

  • Stationary basic diagnostic x-ray system, digital

Q-RAD Radiographic System - 60889976573914

R-CPU-DRX Q-RAD DIGITAL CONSOLE
CARESTREAM HEALTH, INC.
Q-RAD Radiographic System
In Commercial Distribution

  • 60889976573914 ()
6573919

  • Stationary basic diagnostic x-ray system, digital

CARESTREAM DRX-EVOLUTION - 60889976565667

ASSM-UNIVERSAL GRID HOLDER, DRX-EVOLUTIO
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION
In Commercial Distribution

  • 60889976565667 ()
6565667

  • Stationary basic diagnostic x-ray system, digital

CARESTREAM DRX-EVOLUTION - 60889976557655

CARESTREAM DRX BABIX HOLDER
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION
In Commercial Distribution

  • 60889976557655 ()
6557656

  • Stationary basic diagnostic x-ray system, digital

CARESTREAM DRX-EVOLUTION - 60889976551523

MOVEABLE TABLE FOR DR SYS
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION
In Commercial Distribution

  • 60889976551523 ()
6551527

  • Stationary basic diagnostic x-ray system, digital

4343R Digital Image Receptor - 60889974007473

43X43 GOS DETECTOR
CARESTREAM HEALTH, INC.
4343R Digital Image Receptor
In Commercial Distribution

  • 60889974007473 ()
9G9998

  • Stationary basic diagnostic x-ray system, digital

4343R Digital Image Receptor - 60889974007466

DRX-DETECTOR 43X43 CSI FIXED
CARESTREAM HEALTH, INC.
4343R Digital Image Receptor
In Commercial Distribution

  • 60889974007466 ()
9G5716

  • Stationary basic diagnostic x-ray system, digital

4343R Digital Image Receptor - 60889974000375

AY-DETECTOR, TESTED, 43 X 43
CARESTREAM HEALTH, INC.
4343R Digital Image Receptor
In Commercial Distribution

  • 60889974000375 ()
AB8135

  • Stationary basic diagnostic x-ray system, digital

CARESTREAM DRX-EVOLUTION - 60889971963789

80KW GENERATOR/FOR DRX-EVOLUTION
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION
In Commercial Distribution

  • 60889971963789 ()
1963784

  • Stationary basic diagnostic x-ray system, digital

DRX-Evolution Plus System - 60889971741035

DRX-Evolution Plus System (B-PCSH-P-X)
CARESTREAM HEALTH, INC.
DRX-Evolution Plus System
In Commercial Distribution

  • 60889971741035 ()
1741032

  • Stationary basic diagnostic x-ray system, digital

DRX-Evolution Plus System - 60889971739469

DRX-Evolution Plus Transbay OTC System
CARESTREAM HEALTH, INC.
DRX-Evolution Plus System
In Commercial Distribution

  • 60889971739469 ()
1739465

  • Stationary basic diagnostic x-ray system, digital

DRX-Evolution Plus System - 60889971739254

DRX-EVOLUTION Plus - CSH WS w SLIM E-BOX
CARESTREAM HEALTH, INC.
DRX-Evolution Plus System
In Commercial Distribution

  • 60889971739254 ()
1739259

  • Stationary basic diagnostic x-ray system, digital

DRX-Evolution Plus System - 60889971739230

Elevating Table - DRX Evo Plus
CARESTREAM HEALTH, INC.
DRX-Evolution Plus System
In Commercial Distribution

  • 60889971739230 ()
1739234

  • Stationary basic diagnostic x-ray system, digital

DRX-Evolution Plus System - 60889971739223

DRX-Evolution Plus System (P-X-P-X)
CARESTREAM HEALTH, INC.
DRX-Evolution Plus System
In Commercial Distribution

  • 60889971739223 ()
1739226

  • Stationary basic diagnostic x-ray system, digital

DRX-Evolution Plus System - 60889971739216

DRX-Evolution Plus System (P-PCSCH-X-X)
CARESTREAM HEALTH, INC.
DRX-Evolution Plus System
In Commercial Distribution

  • 60889971739216 ()
1739218

  • Stationary basic diagnostic x-ray system, digital

DRX-Evolution Plus System - 60889971739193

DRX-Evolution Plus Automatic - Dual Buck
CARESTREAM HEALTH, INC.
DRX-Evolution Plus System
In Commercial Distribution

  • 60889971739193 ()
1739192

  • Stationary basic diagnostic x-ray system, digital

CARESTREAM DRX-EVOLUTION - 60889971051301

GRID/DRX-EVO WALL 140CM 8:1/40 LN/CM
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION
In Commercial Distribution

  • 60889971051301 ()
1051309

  • Stationary basic diagnostic x-ray system, digital

CARESTREAM DRX-EVOLUTION - 60889971731678

DRX-EVOLUTION/P-PCSH-P-X
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION
Not in Commercial Distribution

  • 60889971731678 ()
1731678

  • Stationary basic diagnostic x-ray system, digital

CARESTREAM DRX-EVOLUTION - 60889971731623

DRX-EVOLUTION/B-BCSH-P-X
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION
In Commercial Distribution

  • 60889971731623 ()
1731629

  • Stationary basic diagnostic x-ray system, digital

DRX-Evolution Plus System - 60889971035141

DRX-EVO MOTOR CSH WS ONLY/X-PCSH4343-X-X
CARESTREAM HEALTH, INC.
DRX-Evolution Plus System
In Commercial Distribution

  • 60889971035141 ()
1035146

  • Stationary basic diagnostic x-ray system, digital

CARESTREAM DRX-EVOLUTION - 60889978001231

DRX-EVOLUTION/P-PCSH-P-X W/WP
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION
In Commercial Distribution

  • 60889978001231 ()
8001232

  • Stationary basic diagnostic x-ray system, digital

CARESTREAM DRX-EVOLUTION - 60889978001194

DRX-EVOLUTION/P-PCSH-P-X W/INWP
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION
In Commercial Distribution

  • 60889978001194 ()
8001190

  • Stationary basic diagnostic x-ray system, digital

CARESTREAM DRX-EVOLUTION - 60889978001170

DRX-EVOLUTION/P-PCSH-P-X
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION
Not in Commercial Distribution

  • 60889978001170 ()
8001174

  • Stationary basic diagnostic x-ray system, digital

DRX-Compass X-ray System - 60889976704899

X-RAY FMT SYSTEM ANALOG CONSOLE PDU C/F
CARESTREAM HEALTH, INC.
DRX-Compass X-ray System
In Commercial Distribution

  • 60889976704899 ()
6704894

  • Stationary basic diagnostic x-ray system, digital

DRX-Compass X-ray System - 60889976704875

X-RAY FMT SYSTEM DIGITAL CONSOLE PDU C/F
CARESTREAM HEALTH, INC.
DRX-Compass X-ray System
In Commercial Distribution

  • 60889976704875 ()
6704878

  • Stationary basic diagnostic x-ray system, digital

Value Systems - 60889976701539

GENERATOR GRP C 65KW 3P 380-480 VAC
CARESTREAM HEALTH, INC.
Value Systems
In Commercial Distribution

  • 60889976701539 ()
6701536

  • Stationary basic diagnostic x-ray system, digital
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