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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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SEDECAL - 08436046001909

The SEDECAL X BRS (BRX) Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SEDECAL X BRS (BRX)
In Commercial Distribution

  • 08436046001909 ()


  • Stationary basic diagnostic x-ray system, analogue

SEDECAL - 08436046001855

This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPSL-HF-8.0-APR
In Commercial Distribution

  • 08436046001855 ()


  • Portable basic diagnostic x-ray system, analogue

SEDECAL - 08436046001848

This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPSL-HF-4.0-APR
In Commercial Distribution

  • 08436046001848 ()


  • Portable basic diagnostic x-ray system, analogue

SEDECAL - 08436046001831

This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPSL-HF-8.0
In Commercial Distribution

  • 08436046001831 ()


  • Portable basic diagnostic x-ray system, analogue

SEDECAL - 08436046001824

This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPSL-HF-4.0
In Commercial Distribution

  • 08436046001824 ()


  • Portable basic diagnostic x-ray system, analogue

SEDECAL - 08436046001794

This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPL-HF-8.0
In Commercial Distribution

  • 08436046001794 ()


  • Portable basic diagnostic x-ray system, analogue

SEDECAL - 08436046001787

This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPL-HF-4.0
In Commercial Distribution

  • 08436046001787 ()


  • Portable basic diagnostic x-ray system, analogue

SEDECAL - 08436046001770

This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPL-HF-2.0
In Commercial Distribution

  • 08436046001770 ()


  • Portable basic diagnostic x-ray system, analogue

SEDECAL - 08436046000933

The SEDECAL X (URS) Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
SEDECAL X (URS)
In Commercial Distribution

  • 08436046000933 ()


  • Stationary basic diagnostic x-ray system, analogue

SEDECAL - 08436046002500

The SEDECAL X URS Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
SEDECAL X URS
In Commercial Distribution



  • Stationary basic diagnostic x-ray system, analogue

MEDIUM TORSO SIMULATOR - 00814848020232

No Description
QUALITY ELECTRODYNAMICS LLC
2001001
In Commercial Distribution

  • 00814848020232 ()
MAC000112

  • Radiation therapy simulation system

HEAD NECK SIMULATOR - 00814848020218

No Description
QUALITY ELECTRODYNAMICS LLC
2001000
In Commercial Distribution

  • 00814848020218 ()
MAC000111

  • Radiation therapy simulation system

vascuCAP - B745VASCUCAPA2

No Description
ELUCID BIOIMAGING INC.
A.2
In Commercial Distribution

  • B745VASCUCAPA2 ()


  • CT system application software

ElucidVivo - B745ELUCIDVIVOA3

No Description
ELUCID BIOIMAGING INC.
A.3
In Commercial Distribution

  • B745ELUCIDVIVOA3 ()


  • CT system application software

vascuCAP - B745A40

No Description
ELUCID BIOIMAGING INC.
A.1.2
In Commercial Distribution

  • B745A40 ()


  • CT system application software

XDR - D787XDRSW300

Dental imaging software
CYBER MEDICAL IMAGING, INC.
Imaging Software
In Commercial Distribution

  • D787XDRSW300 ()
XDRSW30

  • General-purpose dental x-ray system application software

XDR - D787XDRSW1

Dental imaging software
CYBER MEDICAL IMAGING, INC.
Imaging Software
In Commercial Distribution

  • D787XDRSW1 ()
XDRSW

  • General-purpose dental x-ray system application software

Monarch Software Laptop v2.2.1 - B634SW0121940202000

Monarch Software Laptop v2.2.1
AURIS HEALTH, INC.
Version 2.2.1
In Commercial Distribution

  • B634SW0121940202000 ()


  • CT system application software

Monarch Software Laptop v2.1.6 - B634SW0121900201060

Monarch Software Laptop v2.1.6
AURIS HEALTH, INC.
Version 2.1.6
In Commercial Distribution

  • B634SW0121900201060 ()


  • CT system application software

Monarch™ Software Laptop v2.1.5 - B634SW0032760201050

Monarch™ Software Laptop v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution

  • B634SW0032760201050 ()


  • CT system application software
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