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,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
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
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
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
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems DMC GmbH
9897-010-00834
Not in Commercial Distribution

  • 00884838065222 ()


  • Indirect flat panel x-ray detector
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems DMC GmbH
9897-010-00843
Not in Commercial Distribution

  • 00884838065215 ()


  • 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
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
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 Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
F4343-AW
In Commercial Distribution

  • 08806095896144 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
F4335-AW
In Commercial Distribution

  • 08806094744934 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
S4343-AWM
In Commercial Distribution

  • 08806094458220 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
S4335-AWM
In Commercial Distribution

  • 08806094458213 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
S4343-W
In Commercial Distribution

  • 08806088512266 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
S3025-W
In Commercial Distribution

  • 08806088512211 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
S4335-W
In Commercial Distribution

  • 08806086571210 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
S4343-AW
In Commercial Distribution

  • 08801643990107 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
S4335-AW
In Commercial Distribution

  • 08801643990091 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
S4335-WV
In Commercial Distribution

  • 08801643431419 ()


  • 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
Mars1417V-TSI Wireless Flat Panel Detector with only one package
iRay Korea Limited
Mars1417V-TSI
In Commercial Distribution

  • 08800061700015 ()


  • Indirect flat panel x-ray detector
The ADD is a Flat Panel Digital X-ray Detector which have 425.04 x 425.6mm (HAD1717MCW) or 345.24 x 425.6mm (HAD1417MCW) effective pixel area. The device communicates by the wired Ethernet and wireless Wi-Fi communication feature. The detector should be integrated with a Console PC and a X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic (the Console PC and X-Ray Generator are not provided from H&Abyz). The ADD consists of the following components: Flat Panel Detector, power supply box, switch box, cable, battery, and battery recharger.
H&abyz Co., Ltd
HAD1717MCW
In Commercial Distribution

  • 08800070400050 ()
HAD1717MCW

  • Indirect flat panel x-ray detector
The A1717MCW/A1417MCW/F1417MCW is a Flat Panel Digital X-ray Detector which have 425.04 x 425.6mm (A1717MCW) or 345.24 x 425.6mm (A1417MCW/F1417MCW) effective pixel area. The device communicates by the wired Ethernet and wireless Wi-Fi communication feature. The detector should be integrated with a Console PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic (the Console PC and X-Ray Generator are not provided from H&abyz). The A1717MCW/A1417MCW/F1417MCW consists of the following components: Flat Panel Detector, power supply box, cable, battery, and battery recharger.
H&abyz Co., Ltd
F1417MCW
In Commercial Distribution

  • 08800070400043 ()


  • Indirect flat panel x-ray detector
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