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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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OB Legacy System iOS Software System
Airstrip Technologies, Inc.
1001
In Commercial Distribution

  • B15310010 ()


  • Bedside monitor remote-viewing software, physiological parameter
OB Legacy System Server Software System
Airstrip Technologies, Inc.
1000
In Commercial Distribution

  • B15310000 ()


  • Bedside monitor remote-viewing software, physiological parameter
Radixact Delivery System Software (Version 1.1)
ACCURAY INCORPORATED
1060253
In Commercial Distribution

  • M65810602530 ()
N/A

  • Linear accelerator system
Stand-alone software for GoCheck Kids Nokia.
Gobiquity, Inc.
Nokia 4.4.29
In Commercial Distribution

  • B430GCKNOK44290L ()


  • External ocular measurement camera
Clinical Laboratory Information System application software
ASPYRA, LLC
7.3.1
In Commercial Distribution

  • B433CL0 ()
CL731

  • Clinical laboratory information system application software
360CAS KNEE NAVIGATION SYSTEM SOFTWARE v3
KICO KNEE INNOVATION COMPANY PTY LIMITED
3.1.0
In Commercial Distribution

  • B432360CAS3100 ()


  • Robotic surgical navigation system application software
CDR DICOM 5.0 FOR WINDOWS SOFTWARE
SIRONA DENTAL, INC.
B1030191
In Commercial Distribution

  • D764B10301910 ()


  • Diagnostic x-ray digital imaging system workstation application software
Rapid System Update
Ischemaview, Inc.
6.1.0
In Commercial Distribution

  • B761R610 ()


  • Radiological PACS software
Rapid Platform plus cleared indications for Rapid version 6.x
Ischemaview, Inc.
6.x
In Commercial Distribution

  • B761R60 ()


  • Radiological PACS software
360CAS Navigation System Software is a bespoke software developed by Kico for surgical navigation. The software contains two modules, 360CAS Knee and 360CAS Hip.
KICO KNEE INNOVATION COMPANY PTY LIMITED
2.1.0
In Commercial Distribution

  • B432360CAS2100 ()


  • Robotic surgical navigation system application software
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