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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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System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.6
In Commercial Distribution

  • 00850005944119 ()
83-00054-000

  • Magnetic neural stimulation system
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.5
In Commercial Distribution

  • 00850005944089 ()
83-00054-000

  • Magnetic neural stimulation system
No Description
KONICA MINOLTA, INC.
AEVM
In Commercial Distribution

  • 04560141951433 ()


  • Basic diagnostic x-ray system application software
No Description
Omniscient Neurotechnology Pty Ltd (o8t)
2.1
In Commercial Distribution

  • 09358140000055 ()
SCI0006

  • Radiological PACS software
Enterprise
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034120 ()
PLU238

  • Radiology information system application software
US & International
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034110 ()
PLU349

  • Radiology information system application software
Animal
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034090 ()
PLU235

  • Radiology information system application software
Forensic
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034080 ()
PLU236

  • Radiology information system application software
Care Orchestrator Clinical Management Data Software
Respironics, Inc.
1.13
In Commercial Distribution

  • 00606959050730 ()
1126366

  • Medical equipment clinical data interfacing software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2188
In Commercial Distribution

  • 14953170373760 ()
  • 04953170373763 ()
N5400340

  • Video capsule endoscopy system application software
No Description
CANON MEDICAL SYSTEMS CORPORATION
VSTP-002A
In Commercial Distribution

  • 04987670105005 ()


  • Radiological PACS software
The NAVIS-EX image filing software is software that acquires data from the following NIDEK fundus photography devices and files it for easy transfer to external systems. NAVIS-EX is equipped with functions for image acquiring, image display, image drawing, image processing, image measurement, panorama image creation, stereo image observation, composite image creation, and Follow-Up. (According to the image, available functions are limited.) Image data can be transferred by network or e-mail. NAVIS-EX can construct a network among multiple terminals and refers to and edits data from the client PC.
NIDEK CO.,LTD.
NAVIS-EX
In Commercial Distribution

  • 04987669100523 ()


  • Eye anterior segment analyser software
  • Posterior eye segment analyser software
SFW KIT 9735739 STEALTH S8 STEREOTX
MEDTRONIC NAVIGATION, INC.
9735739
In Commercial Distribution

  • 00643169838987 ()


  • Neurological stereotactic surgery system
SFW KIT 9735738 STEALTH S8 CRN DBS
MEDTRONIC NAVIGATION, INC.
9735738
In Commercial Distribution

  • 00643169838970 ()


  • Neurological stereotactic surgery system
SW KIT 9735737 STEALTH S8 CRANIAL
MEDTRONIC NAVIGATION, INC.
9735737
In Commercial Distribution

  • 00643169838963 ()


  • Neurological stereotactic surgery system
No Description
ergoline GmbH
161801
In Commercial Distribution

  • 04059358001838 ()


  • Cardiopulmonary parameter spot-check measurement software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10855671
Not in Commercial Distribution

  • 04056869001067 ()


  • Radiological PACS software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11149926
Not in Commercial Distribution

  • 04056869006840 ()


  • Radiological PACS software
syngo Application Software VD3; covered by NFJ to K170747/K173611 syngo Application Software VD2
Siemens Healthcare GmbH
11328180
In Commercial Distribution

  • 04056869262567 ()


  • Basic diagnostic x-ray system application software
No Description
ACCUTOME, INC.
2.06.02-U
In Commercial Distribution

  • 00897826002147 ()


  • Ophthalmic ultrasound imaging system
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