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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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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

Value Systems - 60889976701522

GENERATOR GRP C 80KW 3P 380-480 VAC
CARESTREAM HEALTH, INC.
Value Systems
In Commercial Distribution

  • 60889976701522 ()
6701528

  • Stationary basic diagnostic x-ray system, digital

DRX-Evolution Plus System - 60889971016140

DRX EVO FIXD ELE TBL MDL VX3733-TAB
CARESTREAM HEALTH, INC.
DRX-Evolution Plus System
Not in Commercial Distribution

  • 60889971016140 ()
1016146

  • Stationary basic diagnostic x-ray system, digital

DRX-Evolution Plus System - 60889971026170

DRX-EVOLUTN PREMIUM CSH WS W/ SLIM E-BOX
CARESTREAM HEALTH, INC.
DRX-Evolution Plus System
Not in Commercial Distribution

  • 60889971026170 ()
1026178

  • Stationary basic diagnostic x-ray system, digital

Freespira - B185SM40500

Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.
Freespira, Inc.
3
In Commercial Distribution

  • B185SM40500 ()
04275

  • Psychophysiological biofeedback system

FST5 - B185FS059370

Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.
Freespira, Inc.
5
In Commercial Distribution

  • B185FS059370 ()


  • Psychophysiological biofeedback system

2020i Straight Arm - 00817100020162

2020i Radiographic Straight Arm system variable focal distance left loading only
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR1000i
In Commercial Distribution

  • 00817100020162 ()
2020SA

  • Stationary basic diagnostic x-ray system, digital

2020i Imaging Hand System - 00817100020155

Dedicated Hand X-Ray system
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR420i
In Commercial Distribution

  • 00817100020155 ()
HDR

  • Stationary basic diagnostic x-ray system, digital

2020 Imaging Podiatry System HF - 00817100020148

X-Ray System, Podiatry DR Ready (70kVp,10mA).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR410i
In Commercial Distribution

  • 00817100020148 ()
PXS-710

  • Stationary basic diagnostic x-ray system, digital

2020 Imaging Podiatry System - 00817100020131

20/20 BiDirectional PDR X-ray Machine.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR400i
In Commercial Distribution

  • 00817100020131 ()
BD715

  • Stationary basic diagnostic x-ray system, digital

Dynamic DR Room - 00817100020100

Platinum Radiographic / Fluoroscopic system 90/90 DRF43 FL with generator and X-Ray tube.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
RF6000
In Commercial Distribution

  • 00817100020100 ()


  • Stationary basic diagnostic x-ray system, digital

Overhead Tube Crane - 00817100020094

NOVA CSAP Ceiling suspension tube stand Motorized with Auto positioning and touch screen panel (to work with auto position table and wall stand versions).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR5200
In Commercial Distribution

  • 00817100020094 ()


  • Stationary basic diagnostic x-ray system, digital

Overhead Tube Crane Ceiling Suspension - 00817100020070

Manual ceiling suspension tube stand ONLY
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR5100
In Commercial Distribution

  • 00817100020070 ()


  • Stationary basic diagnostic x-ray system, digital

Millenium Floor Mounted Tube Stand - 00817100020063

Floor-Mounted Tubestand longitudinal tube travel 2m. with advanced control with Digital SID
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR100
In Commercial Distribution

  • 00817100020063 ()


  • Stationary basic diagnostic x-ray system, digital

Advanced Universal U-Arm Stand 4000 - 00817100020056

Advanced Universal U-arm Stand 4000 - Motorized Auto Positioning and Touchscreen control
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR3500B
In Commercial Distribution

  • 00817100020056 ()


  • Stationary basic diagnostic x-ray system, digital

Advanced Universal U-Arm Stand 3000 - 00817100020049

Advanced Universal U-arm Stand 3000 - 8' Motorized Auto Positioning and Touchscreen control
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR3002
In Commercial Distribution

  • 00817100020049 ()


  • Stationary basic diagnostic x-ray system, digital

U-Arm System - 00817100020032

Universal U-arm system - With Motorized Auto Positioning and Touchscreen control
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR3000
In Commercial Distribution

  • 00817100020032 ()


  • Stationary basic diagnostic x-ray system, digital

U-Arm System Basic - 00817100020025

Universal U-arm system - Motorized.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR3001
In Commercial Distribution

  • 00817100020025 ()


  • Stationary basic diagnostic x-ray system, digital

Straight Arm System - 00817100020018

Universal Radiographic Straight Arm system variable focal distance left loading Only.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR1000
In Commercial Distribution

  • 00817100020018 ()


  • Stationary basic diagnostic x-ray system, digital

CuattroDR - B269SWR00069MD0

CuattroDR System Software
Cuattro Medical
SWR-00069-MD
In Commercial Distribution

  • B269SWR00069MD0 ()


  • Stationary basic diagnostic x-ray system, digital

Radmedix AcuityUDR - 00810035220522

RadmediX AcuityUDR combines components into a complete stationary x-ray system, including tube stand, tube head, collimator, generator, a digital radiography panel, and image acquisition software. 21CFR 892.1680 Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220522 ()


  • Stationary basic diagnostic x-ray system, digital
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