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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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Roentgen Works - 00850631008384

Roentgen Works 5.0.2 is a PACS, RIS, and Viewer.
Brit Systems, LLC
5.0.2
In Commercial Distribution

  • 00850631008384 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software

Roentgen Works - 00850631008377

Roentgen Works 5.0.1 is a PACS, RIS, and Viewer.
Brit Systems, LLC
5.0.1
In Commercial Distribution

  • 00850631008377 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software

Roentgen Works - 00850631008346

Roentgen Works 5.0.0 is a PACS, RIS, and Viewer.
Brit Systems, LLC
5.0.0
In Commercial Distribution

  • 00850631008346 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software

Roentgen Works - 00850631008339

Roentgen Works 4.3.2 is a PACS, RIS, and Viewer.
Brit Systems, LLC
4.3.2
In Commercial Distribution

  • 00850631008339 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software

Roentgen Works - 00850631008322

Roentgen Works 4.3.1 is a PACS, RIS, and Viewer.
Brit Systems, LLC
4.3.1
In Commercial Distribution

  • 00850631008322 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software

Roentgen Works - 00850631008315

Roentgen Works 4.3.0 is a PACS, RIS, and Viewer.
Brit Systems, LLC
4.3.0
In Commercial Distribution

  • 00850631008315 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software

Roentgen Works - 00850631008308

Roentgen Works 4.2.3 is a PACS, RIS, and Viewer.
Brit Systems, LLC
4.2.3
In Commercial Distribution

  • 00850631008308 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software

Roentgen Works - 00850631008292

Roentgen Works 4.2.2 is a PACS, RIS, and Viewer.
Brit Systems, LLC
4.2.2
In Commercial Distribution

  • 00850631008292 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software

Roentgen Works - 00850631008285

Roentgen Works 4.2.1 is a PACS, RIS, and Viewer.
Brit Systems, LLC
4.2.1
In Commercial Distribution

  • 00850631008285 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software

Roentgen Works - 00850631008278

Roentgen Works 4.2.0 is a PACS, RIS, and Viewer.
Brit Systems, LLC
4.2.0
In Commercial Distribution

  • 00850631008278 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software

Roentgen Works - 00850631008261

Roentgen Works 4.1.3 is a PACS, RIS, and Viewer.
Brit Systems, LLC
4.1.3
In Commercial Distribution

  • 00850631008261 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software

Roentgen Works - 00850631008254

Roentgen Works 4.1.2
Brit Systems, LLC
4.1.2
In Commercial Distribution

  • 00850631008254 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software

Roentgen Works - 00850631008735

Roentgen Works 6.6.0 is a PACS, RIS, and Viewer.
Brit Systems, LLC
6.6.0
In Commercial Distribution

  • 00850631008735 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software

NA - M65810604640

Software, TomoApps, Version 5.1.2 Operating Software for TomoTherapy systems (including TomoH®, TomoHD®, TomoHDA) and Onrad Treatment System™
ACCURAY INCORPORATED
1060464
In Commercial Distribution

  • M65810604640 ()
NA

  • Linear accelerator system

TDGenet - 03770027519027

Patient-centric software for genetics laboratories - Tailor-made software for cytogenetics and molecular genetics laboratories, and for coordinating all clinical genetics activities.
TECHNIDATA
TDGenet
In Commercial Distribution

  • 03770027519027 ()


  • Clinical laboratory information system application software

Tobii Dynavox - 07340074601042

Speech Generating Device with a 7" screen on Windows platform. Tobii Dynavox software includes Snap+Corefirst, Compass or Communicator software.
TOBII DYNAVOX LLC
Indi 7
Not in Commercial Distribution

  • 07340074601042 ()
750518

  • Voice synthesizer/digitizer

HeartVista Cardiac Package - B440HVCP030

HeartVista Cardiac Package
Heartvista, Inc.
030004
Not in Commercial Distribution

  • B440HVCP030 ()
HVCP

  • MRI system operator console
  • MRI system operation software
  • MRI system application software

HeartVista Cardiac Package - B440HVCP020

HeartVista Cardiac Package
Heartvista, Inc.
020301
In Commercial Distribution

  • B440HVCP020 ()
HVCP

  • MRI system operator console
  • MRI system operation software
  • MRI system application software

NA - 00856602005017

No Description
PROTEUS DIGITAL HEALTH, INC.
SPC-0800
In Commercial Distribution

  • 10856602005014 ()
  • 00856602005017 ()


  • Medication adherence telemetric monitoring system, post-ingestion

NA - 00643169518957

PROG 8835 PERSONAL THERAPY MGR ROHS
MEDTRONIC, INC.
8835
In Commercial Distribution

  • 00643169518957 ()


  • Infusion pump programmer

NA - 00643169512948

PROG 8835 PERSONAL THERAPY 60601-11
MEDTRONIC, INC.
8835
In Commercial Distribution

  • 00643169512948 ()


  • Infusion pump programmer

i-Dixel - 04548213026982

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213026982 ()


  • Basic diagnostic x-ray system application software

i-Dixel - 04548213026975

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213026975 ()


  • Basic diagnostic x-ray system application software

i-Dixel - 04548213026968

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213026968 ()


  • Basic diagnostic x-ray system application software

i-Dixel - 04548213026951

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213026951 ()


  • Basic diagnostic x-ray system application software

i-Dixel - 04548213026944

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213026944 ()


  • Basic diagnostic x-ray system application software

i-Dixel - 04548213026852

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213026852 ()


  • Basic diagnostic x-ray system application software

i-Dixel - 04548213026845

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213026845 ()


  • Basic diagnostic x-ray system application software

i-Dixel - 04548213026838

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213026838 ()


  • Basic diagnostic x-ray system application software

i-Dixel - 04548213026821

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213026821 ()


  • Basic diagnostic x-ray system application software

i-Dixel - 04548213026814

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213026814 ()


  • Basic diagnostic x-ray system application software

i-Dixel - 04548213026807

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213026807 ()


  • Basic diagnostic x-ray system application software

i-Dixel - 04548213026791

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213026791 ()


  • Basic diagnostic x-ray system application software

i-Dixel - 04548213026784

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213026784 ()


  • Basic diagnostic x-ray system application software

i-Dixel - 04548213026777

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213026777 ()


  • Basic diagnostic x-ray system application software

i-Dixel - 04548213026760

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213026760 ()


  • Basic diagnostic x-ray system application software

i-Dixel - 04548213025299

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213025299 ()


  • Basic diagnostic x-ray system application software

i-Dixel - 04548213025282

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213025282 ()


  • Basic diagnostic x-ray system application software

i-Dixel - 04548213025183

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213025183 ()


  • Basic diagnostic x-ray system application software

i-Dixel - 04548213025176

No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213025176 ()


  • Basic diagnostic x-ray system application software
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