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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The CombiDiagnost R90 is a multi-functional general Radiography/Fluoroscopy (R/F) system.that includes - Adjustable Straps for Patient Support; - Adult headrest; - Ankle Clamps; - Arm Support; - Babix holder vertical stand; - Compression Belt (singles. pull); - Console trolles; - Detector Holder for Patient Bed; - Extra Stitching Ruler; - Hand grips (Pair of); - Handle; - Infusion bottle holder; - Leg Supports (Pair of); - Mattress GXR Systems; - Mobile Detector Holder; - Monitor Ceiling Suspension(Family); - Monitor CS for1 Monitor; - Monitor CS for2 Monitors; - Monitor CS for3 Monitors; - Monitor Trolley Family: - Monitor Trolley for 1 Monitor assembly; - Monitor Trolley for 2 Monitors assembly; - Patient Support for Stitching; - Rotable stool for footrest; - Shoulder supports (Pair of); - Side Bar; - Stretch Grip for VS/VM Stand
Philips Medical Systems DMC GmbH
709031
In Commercial Distribution

  • 00884838101456 ()


  • Indirect flat panel x-ray detector
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems DMC GmbH
4598-012-4298.
Not in Commercial Distribution

  • 00884838084636 ()


  • Indirect flat panel x-ray detector
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems DMC GmbH
4598-013-7583.
Not in Commercial Distribution

  • 00884838086753 ()


  • Indirect flat panel x-ray detector
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems DMC GmbH
9897-010-02681
Not in Commercial Distribution

  • 00884838074705 ()


  • Indirect flat panel x-ray detector
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems DMC GmbH
9890-010-87752
Not in Commercial Distribution

  • 00884838074279 ()
706050

  • Indirect flat panel x-ray detector
Digital X-Ray flat panel detector used to acquire radiographic images of human anatomy when used with existing radiographic x-ray systems.
OSKO, INC.
Edge Air
In Commercial Distribution

  • 00869126000444 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-Ray Detector used to generate images of any part of the body. The system consists of a scintillator directly coupled to an a-Si TFT sensor. The system generates high-resolution and high-sensitive digital images.
OSKO, INC.
Edge
In Commercial Distribution

  • 00869126000437 ()


  • Indirect flat panel x-ray detector
Radiation Protection Shield
RADUX DEVICES, LLC
SS0100
Not in Commercial Distribution

  • 10853714008032 ()
  • 00853714008035 ()
SS0100

  • Radiation shielding panel, portable/mobile
Mobile Radiation Shield
Rampart Ic, LLC
M1128-RTV-02
In Commercial Distribution

  • 00860010101209 ()
M1128-RTV-2

  • Radiation shielding panel, portable/mobile
The Collim-Aid fits onto the collimator, shielding the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation.
Reina Imaging
CA2
In Commercial Distribution

  • 00860001700107 ()


  • Radiation shielding panel, portable/mobile
Regarding Model Number: "-WP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 17HK701G-W, the 510k-approved DXD. "-WP" can be either model number or catalog number.
LG Electronics Inc.
17HK701G-WP
In Commercial Distribution

  • 00719192633148 ()
17HK701G-WP

  • Indirect flat panel x-ray detector
Regarding Model Number: "-WP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 17HK700G-W, the 510k-approved DXD. "-WP" can be either model number or catalog number.
LG Electronics Inc.
17HK700G-WP
In Commercial Distribution

  • 00719192633131 ()
17HK700G-WP

  • Indirect flat panel x-ray detector
Regarding Model Number: "-WP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 14HK701G-W, the 510k-approved DXD. "-WP" can be either model number or catalog number.
LG Electronics Inc.
14HK701G-WP
In Commercial Distribution

  • 00719192633124 ()
14HK701G-WP

  • Indirect flat panel x-ray detector
No Description
LG Electronics Inc.
17HK701G-W
In Commercial Distribution

  • 00719192633117 ()
17HK701G-WA

  • Indirect flat panel x-ray detector
No Description
LG Electronics Inc.
17HK700G-W
In Commercial Distribution

  • 00719192620766 ()
17HK700G-WA

  • Indirect flat panel x-ray detector
No Description
LG Electronics Inc.
14HK701G-W
In Commercial Distribution

  • 00719192620759 ()
14HK701G-WA

  • Indirect flat panel x-ray detector
Radiation Shield, Mobile, Adjustable Height, Compact, 1" Lead
BIODEX MEDICAL SYSTEMS, INC.
042-522
In Commercial Distribution

  • 00718175005224 ()
042-522

  • Radiation shielding panel, portable/mobile
Radiation Shield, Mobile, Adjustable Height, 1" Lead
BIODEX MEDICAL SYSTEMS, INC.
042-519
In Commercial Distribution

  • 00718175005194 ()
042-519

  • Radiation shielding panel, portable/mobile
BARRIER, CLEAR-LEAD, 54.5"Hx30"W,0.5mmPb
BIODEX MEDICAL SYSTEMS, INC.
042-582
Not in Commercial Distribution

  • 00718175000083 ()
042-582

  • Radiation shielding panel, portable/mobile
BARRIER, CLEAR-LEAD, 24"Hx30"W, 0.5mm Pb
BIODEX MEDICAL SYSTEMS, INC.
042-580
Not in Commercial Distribution

  • 00718175000076 ()
042-580

  • Radiation shielding panel, portable/mobile
BARRIER, CLEAR-LEAD, 23"Hx48"W, 1.0mmPb
BIODEX MEDICAL SYSTEMS, INC.
042-585
Not in Commercial Distribution

  • 00718175000069 ()
042-585

  • Radiation shielding panel, portable/mobile
DR Detector
AGFA
6011/111
In Commercial Distribution

  • 05414904252529 ()

  • Width: 30 Centimeter
  • Length: 24 Centimeter
XF6RR

  • Indirect flat panel x-ray detector
DR Detector
AGFA
6011/101
In Commercial Distribution

  • 05414904233313 ()

  • Width: 35 Centimeter
  • Length: 43 Centimeter
XBYXB

  • Indirect flat panel x-ray detector
DR Detector
AGFA
6011/102
In Commercial Distribution

  • 05414904233306 ()

  • Width: 35 Centimeter
  • Length: 43 Centimeter
XBYYD

  • Indirect flat panel x-ray detector
DR Detector
AGFA
6011/103
In Commercial Distribution

  • 05414904233290 ()

  • Width: 43 Centimeter
  • Length: 43 Centimeter
XBYZF

  • Indirect flat panel x-ray detector
DR Detector
AGFA
6011/104
In Commercial Distribution

  • 05414904233283 ()

  • Length: 43 Centimeter
  • Width: 43 Centimeter
XBY1H

  • Indirect flat panel x-ray detector
No Description
AGFA
6007/111
In Commercial Distribution

  • 05414904205280 ()
56FUD

  • Indirect flat panel x-ray detector
No Description
AGFA
6007/110
In Commercial Distribution

  • 05414904205273 ()
56FTB

  • Indirect flat panel x-ray detector
DX-D 40C DETECTOR SET/A
AGFA
6007/200
In Commercial Distribution

  • 05414904200704 ()
55SAF

  • Indirect flat panel x-ray detector
DX-D 40G DETECTOR SET/A
AGFA
6007/100
In Commercial Distribution

  • 05414904200391 ()
55R9B

  • Indirect flat panel x-ray detector
DX-D 45G DETECTOR SET
AGFA
6007/101
In Commercial Distribution

  • 05414904197158 ()
55DLC

  • Indirect flat panel x-ray detector
DX-D 45C DETECTOR SET
AGFA
6007/201
In Commercial Distribution

  • 05414904197141 ()
55DKA

  • Indirect flat panel x-ray detector
IDI,RADIATION SHIELD SYSTEM,PROTEGO,MOBILE,METRIC ACCESSORY RAILS,TOSHIBA,MOBILE BARRIER#A800-0007-TS01
IMAGE DIAGNOSTICS, INC.
Protego MRS System for Toshiba Table Tops w/Metric Accessory Rails
In Commercial Distribution

  • 00850977007973 ()
A800-0007-TS01

  • Radiation shielding panel, portable/mobile
IDI,RADIATION SHIELD SYSTEM,PROTEGO,MOBILE,METRIC ACCESSORY RAILS,GE INNOVA,MOBILE BARRIER#A800-0002-GE01
IMAGE DIAGNOSTICS, INC.
Protego MRS System for GE Table Tops w/Metric Accessory Rails
In Commercial Distribution

  • 00850977007966 ()
A800-0002-GE01

  • Radiation shielding panel, portable/mobile
IDI,PROTEGO,FEMORAL RADIATION SHIELD PAD,BOX OF 15,#X800-0251
IMAGE DIAGNOSTICS, INC.
FEMORAL SHIELD RADIATION SHIELD PAD
Not in Commercial Distribution

  • 00850977007942 ()
X800-0251

  • Radiation shielding panel, portable/mobile
IDI,PROTEGO,RADIAL ARM BOARD RADIATION SHIELD PAD,BOX OF 15,#X800-0147
IMAGE DIAGNOSTICS, INC.
RADIAL ARM BOARD RADIATION SHIELD PAD
Not in Commercial Distribution

  • 00850977007935 ()
X800-0147

  • Radiation shielding panel, portable/mobile
IDI,DUAL ARM SYSTEM,COMPASS FLEX,MOBILE,WITH 4500 LIGHT & COMPASS CONTOUR,DUAL 19 HD MONITOR,#A280-1233
IMAGE DIAGNOSTICS, INC.
Compass Flex w/dual 19" HD monitors
In Commercial Distribution

  • 00850977007850 ()
A280-1233

  • Radiation shielding panel, portable/mobile
IDI,DUAL ARM SYSTEM,COMPASS FLEX,MOBILE,WITH 4500 LIGHT & COMPASS CONTOUR,DUAL 27 HD MONITOR,#A280-1192
IMAGE DIAGNOSTICS, INC.
Compass Flex w/dual 27" HD monitors
In Commercial Distribution

  • 00850977007843 ()
A280-1192

  • Radiation shielding panel, portable/mobile
IDI,DUAL ARM SYSTEM,COMPASS FLEX,MOBILE,WITH 4500 LIGHT & COMPASS CONTOUR,32 4K MONITOR,#A280-1191
IMAGE DIAGNOSTICS, INC.
Compass Flex w/32" 4K monitor
In Commercial Distribution

  • 00850977007836 ()
A280-1191

  • Radiation shielding panel, portable/mobile
IDI,DUAL ARM SYSTEM,COMPASS FLEX,MOBILE,WITH 4500 LIGHT & COMPASS CONTOUR,32 HD MONITOR,#A280-1190
IMAGE DIAGNOSTICS, INC.
Compass Flex w/32" HD monitor
In Commercial Distribution

  • 00850977007829 ()
A280-1190

  • Radiation shielding panel, portable/mobile
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