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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IDI,RADIATION SHIELD SYSTEM,PROTEGO,MOBILE,METRIC ACCESSORY RAILS,PHILIPS,ARTICULATING RADIATION SHIELD#A800-0006-PH02
IMAGE DIAGNOSTICS, INC.
Protego MRS System for Small Table Tops w/Metric Accessory Rails
In Commercial Distribution

  • 00850061871336 ()
A800-0006-PH02

  • Radiation shielding panel, portable/mobile
IDI,RADIATION SHIELD SYSTEM,PROTEGO,MOBILE,METRIC ACCESSORY RAILS,SIEMENS ICONO,ARTICULATING RADIATION SHIELD#A800-0004-SII02
IMAGE DIAGNOSTICS, INC.
Protego MRS System for Large Table Tops w/Metric Accessory Rails
In Commercial Distribution

  • 00850061871329 ()
A800-0004-SII02

  • Radiation shielding panel, portable/mobile
IDI,RADIATION SHIELD SYSTEM,PROTEGO,MOBILE,METRIC ACCESSORY RAILS,SIEMENS ICONO,MOBILE BARRIER#A800-0004-SII01
IMAGE DIAGNOSTICS, INC.
Protego MRS System for Large Table Tops w/Metric Accessory Rails
In Commercial Distribution

  • 00850061871312 ()
A800-0004-SII01

  • Radiation shielding panel, portable/mobile
IDI,RADIATION SHIELD SYSTEM,PROTEGO,MOBILE,METRIC ACCESSORY RAILS,SIEMENS ARTIS,ARTICULATING RADIATION SHIELD#A800-0004-SAI02
IMAGE DIAGNOSTICS, INC.
Protego MRS System for Large Table Tops w/Metric Accessory Rails
In Commercial Distribution

  • 00850061871305 ()
A800-0004-SAI02

  • Radiation shielding panel, portable/mobile
IDI,RADIATION SHIELD SYSTEM,PROTEGO,MOBILE,METRIC ACCESSORY RAILS,GE INNOVA,ARTICULATING RADIATION SHIELD#A800-0002-GE02
IMAGE DIAGNOSTICS, INC.
Protego MRS System for GE Table Tops w/Metric Accessory Rails
In Commercial Distribution

  • 00850061871299 ()
A800-0002-GE02

  • Radiation shielding panel, portable/mobile
IDI,PROTEGO,PAD,SCATTER SHIELD,FEMORAL,CASE OF 15,#X800-0251
IMAGE DIAGNOSTICS, INC.
FEMORAL SHIELD RADIATION SHIELD PAD
In Commercial Distribution

  • 00850061871091 ()
  • 00850061871107 ()
X800-0251

  • Radiation shielding panel, portable/mobile
IDI,PROTEGO,PAD,SCATTER SHIELD,RADIAL ARM,CASE OF 15,#X800-0147
IMAGE DIAGNOSTICS, INC.
RADIAL ARM BOARD RADIATION SHIELD PAD
In Commercial Distribution

  • 00850061871077 ()
  • 00850061871084 ()
X800-0147

  • Radiation shielding panel, portable/mobile
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
IDI,DUAL ARM SYSTEM,COMPASS FLEX,MOBILE,WITH 4500 LIGHT & COMPASS CONTOUR,NO MONITOR,#A280-1189
IMAGE DIAGNOSTICS, INC.
Compass Flex w/no monitor
In Commercial Distribution

  • 00850977007812 ()
A280-1189

  • Radiation shielding panel, portable/mobile
IDI,RADIATION SHIELD SYSTEM,PROTEGO,MOBILE,METRIC ACCESSORY RAILS,PHILIPS,MOBILE BARRIER#A800-0006-PH01
IMAGE DIAGNOSTICS, INC.
Protego MRS System for Small Table Tops w/Metric Accessory Rails
In Commercial Distribution

  • 00850977007782 ()
A800-0006-PH01

  • Radiation shielding panel, portable/mobile
IDI,RADIATION PROTECTION SYSTEM,LEADED ACRYLIC WINDOW,STAND-ALONE,COMPASS FRAME,#A610-0215
IMAGE DIAGNOSTICS, INC.
Compass Frame Stand-Alone Unit
In Commercial Distribution

  • 00850977007775 ()
A610-0215

  • Radiation shielding panel, portable/mobile
IDI,RADIATION PROTECTION SYSTEM,LEADED ACRYLIC WINDOW,STAND-ALONE,COMPASS CONTOUR,#A610-0200
IMAGE DIAGNOSTICS, INC.
Compass Contour Stand-Alone Unit
Not in Commercial Distribution

  • 00850977007768 ()
A610-0200

  • Radiation shielding panel, portable/mobile
IDI,RADIATION SHIELD SYSTEM,PROTEGO,MOBILE,METRIC ACCESSORY RAILS,SIEMENS ARTIS,MOBILE BARRIER#A800-0004-SAI01
IMAGE DIAGNOSTICS, INC.
Protego MRS System for Large Table Tops w/Metric Accessory Rails
In Commercial Distribution

  • 00850977007652 ()
A800-0004-SAI01

  • 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
Mobile Radiation Shield
Rampart Ic, LLC
M1128-RTV-02
In Commercial Distribution

  • 00860010101209 ()
M1128-RTV-2

  • 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
Radiation Protection Shield
RADUX DEVICES, LLC
SS0100
Not in Commercial Distribution

  • 10853714008032 ()
  • 00853714008035 ()
SS0100

  • Radiation shielding panel, portable/mobile
No Description
GE MEDICAL SYSTEMS, INC.
3543
In Commercial Distribution

  • 00840682120807 ()


  • Indirect flat panel x-ray detector
No Description
GE MEDICAL SYSTEMS, INC.
2530
In Commercial Distribution

  • 00840682120784 ()


  • Indirect flat panel x-ray detector
Solid State X-ray Imager (Flat Panel / Digital Imager)
Radisen Co., Ltd.
1417MG
In Commercial Distribution

  • 08800099500090 ()
PEDRA-1417MG

  • Indirect flat panel x-ray detector
Solid State X-ray Imager (Flat Panel / Digital Imager)
Radisen Co., Ltd.
1417MC
In Commercial Distribution

  • 08800099500083 ()
PEDRA-1417MC

  • Indirect flat panel x-ray detector
Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
Radisen Co., Ltd.
17FG
In Commercial Distribution

  • 08800099500069 ()
PEDRA-17FG

  • Indirect flat panel x-ray detector
Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
Radisen Co., Ltd.
17FC
In Commercial Distribution

  • 08800099500052 ()
PEDRA-17FC

  • Indirect flat panel x-ray detector
Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
Radisen Co., Ltd.
1417FG
In Commercial Distribution

  • 08800099500045 ()
PEDRA-1417FG

  • Indirect flat panel x-ray detector
Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
Radisen Co., Ltd.
1417FC
In Commercial Distribution

  • 08800099500038 ()
PEDRA-1417FC

  • Indirect flat panel x-ray detector
Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
Radisen Co., Ltd.
1717DTG
In Commercial Distribution

  • 08800099500021 ()
PEDRA-1717DTG

  • Indirect flat panel x-ray detector
Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
Radisen Co., Ltd.
1717DTC
In Commercial Distribution

  • 08800099500014 ()
PEDRA-1717DTC

  • Indirect flat panel x-ray detector
Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
Radisen Co., Ltd.
17F
In Commercial Distribution

  • 08800099500007 ()
PEDRA-17F

  • Indirect flat panel x-ray detector
Full-Field Digital Mammography System
Rayence Co., Ltd.
2430TCA
In Commercial Distribution

  • 08800018602256 ()


  • Indirect flat panel x-ray detector
X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
Rayence Co., Ltd.
1717WCE-GF
In Commercial Distribution

  • 08800018602249 ()


  • Indirect flat panel x-ray detector
X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
Rayence Co., Ltd.
1717WCE-HS
In Commercial Distribution

  • 08800018602232 ()


  • Indirect flat panel x-ray detector
Solid state x-ray imager(flat panel/digital imager)
Rayence Co., Ltd.
1717WCE-HR
In Commercial Distribution

  • 08800018602225 ()


  • Indirect flat panel x-ray detector
Solid state x-ray imager (flat panel/digital imager)
Rayence Co., Ltd.
1717WCE
In Commercial Distribution

  • 08800018602218 ()


  • Indirect flat panel x-ray detector
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