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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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Navigation Software Fluoro Express - 04056481000509

No Description
Brainlab AG
3.2
Not in Commercial Distribution

  • 04056481000509 ()
22082-01A

  • Robotic surgical navigation system

Avatar Medical Software V1 - 03770026095003

AVATAR MEDICAL Software V1 is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multi-dimensional digital images. AVATAR MEDICAL Software V1 is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
AVATAR MEDICAL
AMS V1
Not in Commercial Distribution

  • 03770026095003 ()


  • Radiology picture archiving and communication system workstation

B-scan Plus: Software Package - 00897826002178

No Description
ACCUTOME, INC.
4.07.02-U
In Commercial Distribution

  • 00897826002178 ()


  • Ophthalmic ultrasound imaging system

UBM Plus: Software Package - 00897826002161

No Description
ACCUTOME, INC.
4.07.02-U
In Commercial Distribution

  • 00897826002161 ()


  • Ophthalmic ultrasound imaging system

B-scan Pro: Software Package - 00897826002154

No Description
ACCUTOME, INC.
1.03.03-U
In Commercial Distribution

  • 00897826002154 ()


  • Ophthalmic ultrasound imaging system

Signature ONE Software Package - 00889024585393

v. 1.0
Orthosoft Inc
302.4018
In Commercial Distribution

  • 00889024585393 ()
302.4018

  • Radiology DICOM image processing application software

Signature ONE Software Package - 00889024647046

v. 1.2
Orthosoft Inc
302.4018
In Commercial Distribution

  • 00889024647046 ()
302.4018

  • Radiology DICOM image processing application software

Signature ONE Software Package - 00889024647039

v. 1.1
Orthosoft Inc
302.4018
In Commercial Distribution

  • 00889024647039 ()
302.4018

  • Radiology DICOM image processing application software

EMAG® SOFTWARE V1.4 - 03573026635046

EMAG software (virtual) version 1.4 also called SP4
BIOMERIEUX SA
1.4
In Commercial Distribution

  • 03573026635046 ()


  • Nucleic acid sample preparation instrument IVD

EMAG® SOFTWARE V1.3 - 03573026613358

EMAG software (virtual) version 1.3 also called SP3
BIOMERIEUX SA
1.3
In Commercial Distribution

  • 03573026613358 ()


  • Nucleic acid sample preparation instrument IVD
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