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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 - 08436046003279

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
SM-IV
In Commercial Distribution

  • 08436046003279 ()
CB32

  • Mobile basic diagnostic x-ray system, analogue

SEDECAL - 08436046003262

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
SM-IV
In Commercial Distribution

  • 08436046003262 ()
CB20

  • Mobile basic diagnostic x-ray system, analogue

SEDECAL - 08436046003095

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
SM-V
In Commercial Distribution

  • 08436046003095 ()
BA32

  • Mobile basic diagnostic x-ray system, analogue

SEDECAL - 08436046003088

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
SM-V
In Commercial Distribution

  • 08436046003088 ()
BA20

  • Mobile basic diagnostic x-ray system, analogue

SEDECAL - 08436046003071

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
SM-V
In Commercial Distribution

  • 08436046003071 ()
BA16

  • Mobile basic diagnostic x-ray system, analogue

SEDECAL - 08436046003064

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
SM-V
In Commercial Distribution

  • 08436046003064 ()
AA32

  • Mobile basic diagnostic x-ray system, analogue

SEDECAL - 08436046003057

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
SM-V
In Commercial Distribution

  • 08436046003057 ()
AA20

  • Mobile basic diagnostic x-ray system, analogue

SEDECAL - 08436046003040

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
SM-V
In Commercial Distribution

  • 08436046003040 ()
AA16

  • Mobile basic diagnostic x-ray system, analogue

Accuray Precision Treatment Planning System - 00811376030092

Accuray Precision™ Treatment Planning System (Version 3.0)
Accuray Incorporated
1063143
In Commercial Distribution

  • 00811376030092 ()
NA

  • Radiation therapy treatment planning workstation

Accuray Precision® Treatment Planning System - 00811376030221

Accuray Precision® Treatment Planning System
Accuray Incorporated
1049210-000
In Commercial Distribution

  • 00811376030221 ()
NA

  • Radiation therapy treatment planning workstation

Accuray Precision Treatment Planning System - 00811376030146

Accuray Precision™ Treatment Planning System (Version 3.1)
Accuray Incorporated
1070891
In Commercial Distribution

  • 00811376030146 ()
NA

  • Radiation therapy treatment planning workstation

TIMS System - 00850951007982

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 49O
Not in Commercial Distribution

  • 00850951007982 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007951

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 48O
Not in Commercial Distribution

  • 00850951007951 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007920

TIMS 2000 FEES connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.
FORESIGHT IMAGING, LLC
TIMS 2000 FEES 48O
Not in Commercial Distribution

  • 00850951007920 ()
061000-FEES

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007906

TIMS 2000 FEES-L connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.
FORESIGHT IMAGING, LLC
TIMS 2000 FEES-L 47O
Not in Commercial Distribution

  • 00850951007906 ()
061000-FEES-L

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007883

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 47O
Not in Commercial Distribution

  • 00850951007883 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007869

TIMS 2000 FEES connects to USB Endo scopes. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.
FORESIGHT IMAGING, LLC
TIMS-FEES-USB 2A
Not in Commercial Distribution

  • 00850951007869 ()
061000-FEES-USB

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007807

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 45O
Not in Commercial Distribution

  • 00850951007807 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007784

TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 SP 45O
Not in Commercial Distribution

  • 00850951007784 ()
061000-2000-SP

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007715

TIMS 500 S connects to all analog, digital and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive.
FORESIGHT IMAGING, LLC
TIMS 500 S 44O
Not in Commercial Distribution

  • 00850951007715 ()
061000-500

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007692

TIMS 2000 FEES connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.
FORESIGHT IMAGING, LLC
TIMS 2000 FEES 43O
Not in Commercial Distribution

  • 00850951007692 ()
061000-FEES

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007685

TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 SP 43O
Not in Commercial Distribution

  • 00850951007685 ()
061000-2000-SP

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007647

TIMS 2000 FEES connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.
FORESIGHT IMAGING, LLC
TIMS 2000 FEES 43N
Not in Commercial Distribution

  • 00850951007647 ()
061000-FEES

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007623

TIMS 2000 FEES-L connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.
FORESIGHT IMAGING, LLC
TIMS 2000 FEES-L 43N
Not in Commercial Distribution

  • 00850951007623 ()
061000-FEES-L

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007609

TIMS 2000 FEES-L connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.
FORESIGHT IMAGING, LLC
TIMS 2000 FEES-L 42M
Not in Commercial Distribution

  • 00850951007609 ()
061000-FEES-L

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007586

TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 SP 42M
Not in Commercial Distribution

  • 00850951007586 ()
061000-2000-SP

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007562

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 42M
Not in Commercial Distribution

  • 00850951007562 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007531

TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 SP 42N
Not in Commercial Distribution

  • 00850951007531 ()
061000-2000-SP

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007500

TIMS 2000 FEES connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.
FORESIGHT IMAGING, LLC
TIMS 2000 FEES 42N
Not in Commercial Distribution

  • 00850951007500 ()
061000-FEES

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007487

TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive.
FORESIGHT IMAGING, LLC
TIMS 500 41M
Not in Commercial Distribution

  • 00850951007487 ()
061000-500

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007470

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 41M
Not in Commercial Distribution

  • 00850951007470 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007463

TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 SP 41M
Not in Commercial Distribution

  • 00850951007463 ()
061000-2000-SP

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007456

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 40M
Not in Commercial Distribution

  • 00850951007456 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007449

TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 SP 40M
Not in Commercial Distribution

  • 00850951007449 ()
061000-2000-SP

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007432

TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive.
FORESIGHT IMAGING, LLC
TIMS 500 40M
Not in Commercial Distribution

  • 00850951007432 ()
061000-500

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007425

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 39M
Not in Commercial Distribution

  • 00850951007425 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007418

TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 SP 39M
Not in Commercial Distribution

  • 00850951007418 ()
061000-2000-SP

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007401

TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive.
FORESIGHT IMAGING, LLC
TIMS 500 39M
Not in Commercial Distribution

  • 00850951007401 ()
061000-500

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007258

TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 SP 32L
Not in Commercial Distribution

  • 00850951007258 ()
061000-2000-SP

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007173

TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive.
FORESIGHT IMAGING, LLC
TIMS 500 30K
Not in Commercial Distribution

  • 00850951007173 ()
061000-500

  • Radiology picture archiving and communication system workstation
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