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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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Annalise Critical Care AI - G140ANNALISECONTAINER60

CXR software versions 2.4.X+ Annalise Critical Care AI is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
CXR - 2.4+
In Commercial Distribution

  • G140ANNALISECONTAINER60 ()
Annalisecontainer6

  • X-ray image interpretive software

IDENTIFY - EHUQHQ0100707

The intended use of the device is to identify the patient and patient specific accessories and to guide the positioning of patients and accessories for radiosurgery or radiotherapy prodedures. The only location where the device is used is the radiologic diagnostic and radiation therapy department.
humediQ global GmbH
1.7
In Commercial Distribution

  • EHUQHQ0100707 ()
HQ01007

  • Radio-frequency identification patient positioning/tracking system application software

Vision RT - B120ALIGNRT0

No Description
VISION RT LIMITED
AlignRT
Not in Commercial Distribution

  • B120ALIGNRT0 ()
AlignRT

  • Radiological video camera patient positioning/tracking system

Radixact™ Treatment Delivery System - M65810602530

Radixact Delivery System Software (Version 1.1)
ACCURAY INCORPORATED
1060253
In Commercial Distribution

  • M65810602530 ()
N/A

  • Linear accelerator system

CAPILLAROSCOPE HIGH RESOLUTION WITH PROFESSIONAL SOFTWARE - B1623181

CAPILLAROSCOPE HIGH RESOLUTION WITH PROFESSIONAL SOFTWARE
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-318
Not in Commercial Distribution

  • B1623181 ()
FEDMEDMICFIP5MSWC_US

  • Otoscope, direct

AirStrip OB Legacy iOS - B15310010

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

  • B15310010 ()


  • Bedside monitor remote-viewing software, physiological parameter

AirStrip OB Legacy Server - B15310000

OB Legacy System Server Software System
Airstrip Technologies, Inc.
1000
In Commercial Distribution

  • B15310000 ()


  • Bedside monitor remote-viewing software, physiological parameter

Cardiostation Premier Stand Alone Software - B147CSS0

Cardiostation Software sold with wireless devices.
UNIVERSAL MEDICAL, INC.
Cardiostation Standalone Software
In Commercial Distribution

  • B147CSS0 ()


  • Electrocardiography telemetric monitoring system

Cardiostation® Advantage Software - B147CA0

Cardiostation Software sold with TTM module.
UNIVERSAL MEDICAL, INC.
Cardiostation® Advantage Software
In Commercial Distribution

  • B147CA0 ()


  • Electrocardiography telemetric monitoring system

CDR DICOM - D764B10301910

CDR DICOM 5.0 FOR WINDOWS SOFTWARE
SIRONA DENTAL, INC.
B1030191
In Commercial Distribution

  • D764B10301910 ()


  • Diagnostic x-ray digital imaging system workstation application software
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