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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Mobile 'SEE-THRU' Adjustable Shield
KENEX (ELECTRO-MEDICAL) LIMITED
310/B-3
In Commercial Distribution

  • 05055449401807 ()
310/B-3

  • Radiation shielding panel, portable/mobile
1340/3 Mob Tableside Control Pedestal(7.7x25mm section)
KENEX (ELECTRO-MEDICAL) LIMITED
1340/3
In Commercial Distribution

  • 05055449415750 ()
1340/3

  • Radiation shielding panel, portable/mobile
1340/3/10/LR Mob Tableside Control Pedestal (10x25mmSect) & shield
KENEX (ELECTRO-MEDICAL) LIMITED
1340/3/10/LR
In Commercial Distribution

  • 05055449415675 ()
1340/3/10/LR

  • Radiation shielding panel, portable/mobile
1340/3/LR Mob Tableside Control Pedestal (7.7x25mmSect) & shield
KENEX (ELECTRO-MEDICAL) LIMITED
1340/3/LR
In Commercial Distribution

  • 05055449415743 ()
1340/3/LR

  • Radiation shielding panel, portable/mobile
1340/3/10 Mob Tableside Control Pedestal(10x25mm section)
KENEX (ELECTRO-MEDICAL) LIMITED
1340/3/10
In Commercial Distribution

  • 05055449415668 ()
1340/3/10

  • 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
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
No Description
ALIMED, INC.
932527
In Commercial Distribution

  • 00733657240313 ()
2970013575

  • Radiation shielding panel, portable/mobile
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
4598-013-7583.
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
9897-010-00834
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
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
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
No Description
LG Electronics Inc.
14HK701G-W
In Commercial Distribution

  • 00719192620759 ()
14HK701G-WA

  • Indirect flat panel x-ray detector
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
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
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, 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
The ClearVision ExamVue Flat Panel Detector consists of a line of 3 different models of solid state x-ray detectors, of differing size and characteristics, designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. The ClearVision ExamVue Flat Panel Detector captures digital images of anatomy through the conversion of x-rays to electronic signals, eliminating the need for film or chemical processing to create a hard copy image. The ClearVision ExamVue Flat Panel Detector incorporates the ExamVueDR software, which performs the processing, presentation and storage of the image in DICOM format. All models of the ClearVision ExamVue Flat Panel Detector use aSi TFTD for the collection of light generated by a CsI scintillator, for the purpose of creating a digital x-ray image. The three available models are: a. A 14x17in (35x43cm) tethered cassette sized panel b. A 14x17in (35x43cm) wireless cassette sized panel with automatic exposure detection c. A 17x17in (43x43cm) tethered panel for fixed installations.
JPI HEALTHCARE. CO., LTD.
ClearVision ExamVue Flat Panel Detector
In Commercial Distribution

  • 08809413810013 ()


  • Indirect flat panel x-ray detector
No Description
VIEWORKS CO., LTD.
FXRD-1751SA
In Commercial Distribution

  • 08809394330678 ()


  • Indirect flat panel x-ray detector
No Description
VIEWORKS CO., LTD.
FXRD-4386WB
In Commercial Distribution

  • 08809394330616 ()


  • Indirect flat panel x-ray detector
No Description
VIEWORKS CO., LTD.
FXRD-4343FAW
In Commercial Distribution

  • 08809394330609 ()


  • Indirect flat panel x-ray detector
No Description
VIEWORKS CO., LTD.
FXRD-3643FAW
In Commercial Distribution

  • 08809394330593 ()


  • Indirect flat panel x-ray detector
No Description
VIEWORKS CO., LTD.
FXRD-2530FAW
In Commercial Distribution

  • 08809394330586 ()


  • Indirect flat panel x-ray detector
No Description
VIEWORKS CO., LTD.
FXMD-2430S
In Commercial Distribution

  • 08809394330364 ()


  • Indirect flat panel x-ray detector
No Description
VIEWORKS CO., LTD.
FXMD-1008S
In Commercial Distribution

  • 08809394330357 ()


  • Indirect flat panel x-ray detector
Flat Panel Detector, wireless 43cm by 43 cm of size
VIEWORKS CO., LTD.
FXRD-4343VAW PLUS
In Commercial Distribution

  • 08809394330340 ()


  • Indirect flat panel x-ray detector
Flat Panel Detector, wireless 43cm by 43cm of size
VIEWORKS CO., LTD.
FXRD-4343VAW
In Commercial Distribution

  • 08809394330333 ()


  • Indirect flat panel x-ray detector
Flat Panel Detector, wireless 36cm by 43 cm of size
VIEWORKS CO., LTD.
FXRD-3643VAW PLUS
In Commercial Distribution

  • 08809394330326 ()


  • Indirect flat panel x-ray detector
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