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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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ATAL 9 - 08809378240054

ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel detect. A built-in a-Si TFT flat panel type digital sensor receives X-Ray and converts to digital image. X-Ray photons are converted to digital output signals. The digital signals are then read out by TFTs. The image data file is saved at the computer for display, which can be linked with PACS and printed by DICOM printer through acquisition software. It is specifically designed to deliver X-Ray imaging for medical, veterinary and industrial applications.
PIXXGEN Corporation
ATAL 9 (ATCB-9)
In Commercial Distribution

  • 08809378240054 ()


  • Indirect flat panel x-ray detector

ATAL 9 - 08809378240047

ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel detect. A built-in a-Si TFT flat panel type digital sensor receives X-Ray and converts to digital image. X-Ray photons are converted to digital output signals. The digital signals are then read out by TFTs. The image data file is saved at the computer for display, which can be linked with PACS and printed by DICOM printer through acquisition software. It is specifically designed to deliver X-Ray imaging for medical, veterinary and industrial applications.
PIXXGEN Corporation
ATAL 9 (Portable Detector)
In Commercial Distribution

  • 08809378240047 ()


  • Indirect flat panel x-ray detector

ATAL 9 - 08809378240030

ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel detect. A built-in a-Si TFT flat panel type digital sensor receives X-Ray and converts to digital image. X-Ray photons are converted to digital output signals. The digital signals are then read out by TFTs. The image data file is saved at the computer for display, which can be linked with PACS and printed by DICOM printer through acquisition software. It is specifically designed to deliver X-Ray imaging for medical, veterinary and industrial applications. ATTENTION
PIXXGEN Corporation
ATAL 9 (Wireless Detector)
In Commercial Distribution

  • 08809378240030 ()


  • Indirect flat panel x-ray detector

ATAL 9 - 08809378240023

ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel detect. A built-in a-Si TFT flat panel type digital sensor receives X-Ray and converts to digital image. X-Ray photons are converted to digital output signals. The digital signals are then read out by TFTs. The image data file is saved at the computer for display, which can be linked with PACS and printed by DICOM printer through acquisition software. It is specifically designed to deliver X-Ray imaging for medical, veterinary and industrial applications.
PIXXGEN Corporation
ATAL 9 (Wired Detector)
In Commercial Distribution

  • 08809378240023 ()


  • Indirect flat panel x-ray detector

NA - 08806095896144

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

NA - 08806094744934

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

NA - 08806094458220

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

NA - 08806094458213

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

NA - 08806088512266

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

NA - 08806088512211

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

NA - 08806086571210

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

NA - 08801643990107

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

NA - 08801643990091

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

NA - 08801643431419

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

Techno-Aide - G242MB3060G209

Mobile Radiation Barrier 30x60 window 2mmPbeq
Techno-Aide, Inc.
MB3060G20
In Commercial Distribution

  • G242MB3060G2090 ()
  • G242MB3060G209 ()
MB3060G20

  • Radiation shielding panel, portable/mobile

Techno-Aide - G242MB2430G209

Mobile Radiation Barrier 24x30 window 2mmPbeq
Techno-Aide, Inc.
MB2430G20
In Commercial Distribution

  • G242MB2430G2090 ()
  • G242MB2430G209 ()
MB2430G20

  • Radiation shielding panel, portable/mobile

Techno-Aide - G242LPST3042S9

DELUXE SHIELD - 30 x 42 - 0.50mm Lead Equivalence -REGULAR LEADED PROTECTIVE MEDIA - T Base
Techno-Aide, Inc.
LPS-T3042S
In Commercial Distribution

  • G242LPST3042S90 ()
  • G242LPST3042S9 ()
LPS-T3042S

  • Radiation shielding panel, portable/mobile

Techno-Aide - G242LPST3036S9

DELUXE SHIELD - 30 x 36 - 0.50mm Lead Equivalence -REGULAR LEADED PROTECTIVE MEDIA - T Base
Techno-Aide, Inc.
LPS-T3036S
In Commercial Distribution

  • G242LPST3036S90 ()
  • G242LPST3036S9 ()
LPS-T3036S

  • Radiation shielding panel, portable/mobile

Techno-Aide - G242LPST3030S9

DELUXE SHIELD - 30 x 30 - 0.50mm Lead Equivalence -REGULAR LEADED PROTECTIVE MEDIA - T Base
Techno-Aide, Inc.
LPS-T3030S
In Commercial Distribution

  • G242LPST3030S90 ()
  • G242LPST3030S9 ()
LPS-T3030S

  • Radiation shielding panel, portable/mobile

Techno-Aide - G242LPST2448S9

DELUXE SHIELD - 24 x 48 - 0.50mm Lead Equivalence -REGULAR LEADED PROTECTIVE MEDIA - T Base
Techno-Aide, Inc.
LPS-T2448S
In Commercial Distribution

  • G242LPST2448S90 ()
  • G242LPST2448S9 ()
LPS-T2448S

  • Radiation shielding panel, portable/mobile

Techno-Aide - G242LPST2436S9

DELUXE SHIELD - 24 x 36 - 0.50mm Lead Equivalence -REGULAR LEADED PROTECTIVE MEDIA - T Base
Techno-Aide, Inc.
LPS-T2436S
In Commercial Distribution

  • G242LPST2436S90 ()
  • G242LPST2436S9 ()
LPS-T2436S

  • Radiation shielding panel, portable/mobile

Techno-Aide - G242LPST2430S9

DELUXE SHIELD - 24 x 30 - 0.50mm Lead Equivalence -REGULAR LEADED PROTECTIVE MEDIA - T Base
Techno-Aide, Inc.
LPS-T2430S
In Commercial Distribution

  • G242LPST2430S90 ()
  • G242LPST2430S9 ()
LPS-T2430S

  • Radiation shielding panel, portable/mobile

Techno-Aide - G242LPST2424S9

DELUXE SHIELD - 24 x 24 - 0.50mm Lead Equivalence -REGULAR LEADED PROTECTIVE MEDIA - T Base
Techno-Aide, Inc.
LPS-T2424S
In Commercial Distribution

  • G242LPST2424S90 ()
  • G242LPST2424S9 ()
LPS-T2424S

  • Radiation shielding panel, portable/mobile

Techno-Aide - G242LPSS24489

STANDARD SHIELD - 24 x 48 - 0.50mm Lead Equivalence -REGULAR LEADED PROTECTIVE MEDIA - Star Base
Techno-Aide, Inc.
LPS-S2448
In Commercial Distribution

  • G242LPSS244890 ()
  • G242LPSS24489 ()
LPS-S2448

  • Radiation shielding panel, portable/mobile

Techno-Aide - G242LPSS24369

STANDARD SHIELD - 24 x 36 - 0.50mm Lead Equivalence -REGULAR LEADED PROTECTIVE MEDIA - Star Base
Techno-Aide, Inc.
LPS-S2436
In Commercial Distribution

  • G242LPSS243690 ()
  • G242LPSS24369 ()
LPS-S2436

  • Radiation shielding panel, portable/mobile

Techno-Aide - G242LPSS24249

STANDARD SHIELD - 24 x 24 - 0.50mm Lead Equivalence -REGULAR LEADED PROTECTIVE MEDIA - Star Base
Techno-Aide, Inc.
LPS-S2424
In Commercial Distribution

  • G242LPSS242490 ()
  • G242LPSS24249 ()
LPS-S2424

  • Radiation shielding panel, portable/mobile

Techno-Aide - G242LPSH48489

MAX SHIELD - 48 x 48 - 0.50mm Lead Equivalence -REGULAR LEADED PROTECTIVE MEDIA - H Base
Techno-Aide, Inc.
LPS-H4848
In Commercial Distribution

  • G242LPSH484890 ()
  • G242LPSH48489 ()
LPS-H4848

  • Radiation shielding panel, portable/mobile

Techno-Aide - G242LPSH36369

MAX SHIELD - 36 x 36 - 0.50mm Lead Equivalence -REGULAR LEADED PROTECTIVE MEDIA - H Base
Techno-Aide, Inc.
LPS-H3636
In Commercial Distribution

  • G242LPSH363690 ()
  • G242LPSH36369 ()
LPS-H3636

  • Radiation shielding panel, portable/mobile

Techno-Aide - G242LPSGS24489

STANDARD SHIELD - 24 x 48 - 0.50mm Lead Equivalence -LEAD FREE PROTECTIVE MEDIA - Star Base
Techno-Aide, Inc.
LPSG-S2448
In Commercial Distribution

  • G242LPSGS244890 ()
  • G242LPSGS24489 ()
LPSG-S2448

  • Radiation shielding panel, portable/mobile

Techno-Aide - G242LPSGS24369

STANDARD SHIELD - 24 x 36 - 0.50mm Lead Equivalence -LEAD FREE PROTECTIVE MEDIA - Star Base
Techno-Aide, Inc.
LPSG-S2436
In Commercial Distribution

  • G242LPSGS243690 ()
  • G242LPSGS24369 ()
LPSG-S2436

  • Radiation shielding panel, portable/mobile

Techno-Aide - G242LPSGS24249

STANDARD SHIELD - 24 x 24 - 0.50mm Lead Equivalence -LEAD FREE PROTECTIVE MEDIA - Star Base
Techno-Aide, Inc.
LPSG-S2424
In Commercial Distribution

  • G242LPSGS242490 ()
  • G242LPSGS24249 ()
LPSG-S2424

  • Radiation shielding panel, portable/mobile

THALES - 08054890480154

The detector is suitable for acquiring digital images in radiography modes. It allows radiological diagnostic examinations to be performed in real time. The acquired images are saved in the system memory, displayed on a high definition monitor (HD) and eventually transmitted to a diagnostic workstation. An intermediate storage of images is performed if a wireless connection is not available.
GENERAL MEDICAL MERATE SPA
Pixium 3543EZ
In Commercial Distribution

  • 08054890480154 ()


  • Indirect flat panel x-ray detector

THALES - 08054890480147

The detector is suitable for acquiring digital images in radiography modes. It allows radiological diagnostic examinations to be performed in real time. The acquired images are saved in the system memory, displayed on a high definition monitor (HD) and eventually transmitted to a diagnostic workstation. An intermediate storage of images is performed if a wireless connection is not available.
GENERAL MEDICAL MERATE SPA
Pixium 2430EZ
In Commercial Distribution

  • 08054890480147 ()


  • Indirect flat panel x-ray detector

XRpad2 - 00810751030078

XRpad2 is a lightweight, cassette-sized flat panel detector for digital radiography.
VAREX IMAGING CORPORATION
3025 HWC-M
In Commercial Distribution

  • 00810751030078 ()


  • Indirect flat panel x-ray detector

XRpad - 00810751030054

The Varex Imaging XRpad 4343 F MED is a lightweight, cassette-sized flat panel detector for digital radiography. It fits into a conventional table or wall-stand bucky, just like a film-screen cassette. Featuring a 18.7 million pixel image matrix, a best-in-class 100 um pixel pitch, and a direct deposited CsI scintillator, the XRpad 4343 F MED provides exceptional image quality with a true 43 cm × 43 cm imaging area. A robust and lightweight aluminum frame with carbon-fiber entrance window allows for easier placement and cleaning. Automatic Exposure Detection simplifies integration.
VAREX IMAGING WEST, LLC
4343 F MED
In Commercial Distribution


  • Width: 460 Millimeter
  • Weight: 4.1 Kilogram
  • Depth: 15 Millimeter
  • Length: 460 Millimeter
95510935-02

  • Indirect flat panel x-ray detector

XRPad2 - 00810751030047

XRpad2 4336 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before. Featuring best-in-class 100 um pixel size, direct deposition CsI scintillator and excellent DQE, XRpad2 4336 enables high resolution imaging with reduced X-ray exposure. Design of the second-generation XRpad is lightweight, robust and ergonomic, permitting easy lifting from table top. Automatic Exposure Detection, on-board corrections, and wireless access point mode make system integration quick and simple. New features of the XRpad2 4336 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 8 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.
VAREX IMAGING WEST, LLC
4336 HWC-M
In Commercial Distribution


  • Depth: 15.5 Millimeter
  • Length: 460 Millimeter
  • Width: 384 Millimeter
  • Weight: 3.2 Kilogram
95510981

  • Indirect flat panel x-ray detector

XRPad2 - 00810751030030

XRpad2 3025 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before. Featuring best-in-class 100 um pixel size, direct deposition CsI scintillator and excellent DQE, XRpad2 3025 enables high resolution imaging with reduced X-ray exposure. Design of the second-generation XRpad is lightweight, robust and ergonomic, permitting easy lifting from table top. Automatic Exposure Detection, on-board corrections, and wireless access point mode make system integration quick and simple. New features of the XRpad2 3025 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 10 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.
VAREX IMAGING WEST, LLC
3025 HWC-M
In Commercial Distribution


  • Depth: 15.5 Millimeter
  • Length: 332 Millimeter
  • Width: 282 Millimeter
  • Weight: 1.8 Kilogram
95510991

  • Indirect flat panel x-ray detector

XRPad2 - 00810751030009

XRpad2 4343 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before. Featuring best-in-class 100 um pixel size, direct deposition CsI scintillator and excellent DQE, XRpad2 4343 enables high resolution imaging with reduced X-ray exposure. Design of the second-generation XRpad is lightweight, robust and ergonomic, permitting easy lifting from table top. Automatic Exposure Detection, on-board corrections, and wireless access point mode make system integration quick and simple. New features of the XRpad2 4343 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 8 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.
VAREX IMAGING WEST, LLC
4343 HWC-M
In Commercial Distribution

  • 00810751030009 ()

  • Depth: 15.5 Millimeter
  • Length: 460 Millimeter
  • Width: 460 Millimeter
  • Weight: 3.8 Kilogram
95510607

  • Indirect flat panel x-ray detector

RF 11X14 Sensor Panel - 00817100020513

DR-PANEL-LT1114-L / R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN292
In Commercial Distribution

  • 00817100020513 ()


  • Indirect flat panel x-ray detector

RF 11X14 Sensor Panel - 00817100020483

RF 11X14 Sensor Panel -R/-L
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN291
In Commercial Distribution

  • 00817100020483 ()


  • Indirect flat panel x-ray detector
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