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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No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360TRIAGEICH1110 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
1.0
In Commercial Distribution

  • B720BX360ELUNG100 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360ECTP1110 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.3
In Commercial Distribution

  • B720BX360ECTA1130 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360ECTA1110 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.3
In Commercial Distribution

  • B720BX360EASPECTS113 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360EASPECTS1110 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360TRIAGELVO1110 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360EMRI1110 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
2.1
In Commercial Distribution

  • B720BX360ELUNG210 ()


  • X-ray image interpretive software
Critical Care Suite 2.1, Designated Medical Device
GE MEDICAL SYSTEMS, INC.
2.1
In Commercial Distribution

  • 00195278789365 ()


  • X-ray image interpretive software
Designated Medical Device, Critical Care Suite PACS 1.0
GE MEDICAL SYSTEMS, INC.
PACS 1.0
In Commercial Distribution

  • 00840682147231 ()


  • X-ray image interpretive software
No Description
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 00840682146340 ()


  • X-ray image interpretive software
No Description
VUNO Inc.
VN-M-30
In Commercial Distribution

  • 08800045800342 ()


  • X-ray image interpretive software
No Description
Lunit Inc.
1.1
In Commercial Distribution

  • 08800076000162 ()


  • X-ray image interpretive software
Linux version
Lunit Inc.
1.0
In Commercial Distribution

  • 08800076000124 ()


  • X-ray image interpretive software
Lunit INSIGHT CXR Triage - Windows version
Lunit Inc.
1.0
In Commercial Distribution

  • 08800076000179 ()


  • X-ray image interpretive software
No Description
Lunit Inc.
1.0
In Commercial Distribution

  • 08800076000148 ()


  • X-ray image interpretive software
No Description
Lunit Inc.
1.1
In Commercial Distribution

  • 08800076000056 ()


  • X-ray image interpretive software
Critical Care Suite 2.0, Designated Medical Device
GE MEDICAL SYSTEMS, INC.
2.0
In Commercial Distribution

  • 00195278217981 ()


  • X-ray image interpretive software
No Description
GENORAY CO., LTD.
Zenis
In Commercial Distribution

  • 08809244060137 ()


  • X-ray image interpretive software
The SMILE-100 System is a breast thermography device with a visualization tool that helps a healthcare personnel to review, measure and analyze thermally significant indications in the breast region. It is intended to be used in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or an environment where patient care is provided by qualified healthcare personnel.
NIRAMAI HEALTH ANALYTIX PRIVATE LIMITED
v4.8.0
In Commercial Distribution

  • 08908019450057 ()
NA

  • Infrared thermography interpretive software
IB Lab LAMA is a fully-automated radiological image processing software device intended to aid users in the measurement of limb-length discrepancy and quantitative knee alignment parameters on uni- and bilateral AP full leg radiographs of individuals at least 22 years of age. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The software device is intended to be used by healthcare professionals trained in radiology. IB Lab LAMA is not indicated for use on radiographs on which Ankle Arthroplasties and/or Unicompartmental Knee Arthroplasties are present.
IB Lab GmbH
V1.06
In Commercial Distribution

  • 09120105730730 ()


  • X-ray image interpretive software
The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices.
IB Lab GmbH
V2.11
Not in Commercial Distribution

  • 09120105730471 ()
  • 09120105730464 ()


  • X-ray image interpretive software
The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices.
IB Lab GmbH
V2.05
Not in Commercial Distribution

  • 09120105730082 ()
  • 09120105730037 ()


  • X-ray image interpretive software
software versions 3.6.0, 3.7.0, 3.7.1, 3.8.0, 3.9.0 Annalise Triage (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
3.6.0+
In Commercial Distribution

  • G140ANNALISEENTP50 ()
AnnaliseENTP5

  • X-ray image interpretive software
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
Quantum Warm XL LED Surgical Headlight
Enova Illumination, Inc.
5460-700-046
In Commercial Distribution

  • 00850025993791 ()


  • Head-worn lamp
Quantum Cool XL LED Surgical Headlight
Enova Illumination, Inc.
5460-700-045
In Commercial Distribution

  • 00850025993784 ()


  • Head-worn lamp
Quantum Deluxe Comfort Pad Set - 10 Pack
Enova Illumination, Inc.
5460-700-040
In Commercial Distribution

  • 00850025993241 ()
5460-700-040

  • Head-worn lamp
Quantum Deluxe Comfort Pad Set - 3 Pack
Enova Illumination, Inc.
5460-700-038
In Commercial Distribution

  • 00850025993227 ()
5460-700-038

  • Head-worn lamp
Quantum Warm LED Surgical Headlight
Enova Illumination, Inc.
5460-700-012
In Commercial Distribution

  • 00850025993203 ()
5460-700-012

  • Head-worn lamp
Quantum Cool LED Surgical Headlight
Enova Illumination, Inc.
5460-700-011
In Commercial Distribution

  • 00850025993173 ()
5460-700-011

  • Head-worn lamp
Quantum Occipital Comfort Pad
Enova Illumination, Inc.
5460-700-026
In Commercial Distribution

  • 00850025993111 ()
5460-700-026

  • Head-worn lamp
Quantum Deluxe Comfort Pad Set
Enova Illumination, Inc.
5460-700-027
In Commercial Distribution

  • 00850025993081 ()
5460-700-027

  • Head-worn lamp
Quantum Occipital Mesh Replacement
Enova Illumination, Inc.
5460-700-030
In Commercial Distribution

  • 00850025993074 ()
5460-700-030

  • Head-worn lamp
Quantum Smart Occluder - Right Hand
SPECTRUM MEDICAL LIMITED
QSOR
In Commercial Distribution

  • 05060434424051 ()
51-000074-02

  • Cardiopulmonary bypass system air bubble/fluid level detector
Quantum Smart Occluder - Left Hand
SPECTRUM MEDICAL LIMITED
QSOL
In Commercial Distribution

  • 05060434424044 ()
51-000022-02

  • Cardiopulmonary bypass system air bubble/fluid level detector
Quantum Reservoir Level Sensor Cradle - Curved Taper
SPECTRUM MEDICAL LIMITED
LSC_HRCT
In Commercial Distribution

  • 25060434423980 ()
  • 05060434423986 ()
LSC_HRCT

  • Sensor holder, single-use
Quantum Reservoir Level Sensor Cradle - R70.5
SPECTRUM MEDICAL LIMITED
LSC_HRC70
In Commercial Distribution

  • 25060434423973 ()
  • 05060434423979 ()
LSC_HRC70

  • Sensor holder, single-use
Quantum Reservoir Level Sensor Cradle - Flat
SPECTRUM MEDICAL LIMITED
LSC_HRF
In Commercial Distribution

  • 25060434423966 ()
  • 05060434423962 ()
LSC_HRF

  • Sensor holder, single-use
IRMA Adaptor Kit
SPECTRUM MEDICAL LIMITED
52-000096-00
In Commercial Distribution

  • 15060434423839 ()
  • 05060434423832 ()
52-000096-00

  • Cardiopulmonary bypass system gas control unit
Gas Sample Line Kit
SPECTRUM MEDICAL LIMITED
52-000095-00
In Commercial Distribution

  • 15060434423815 ()
  • 05060434423818 ()
52-000095-00

  • Cardiopulmonary bypass system gas control unit
CoolFlow SM.03.DTX Heat Transfer Fluid 1.5L
SPECTRUM MEDICAL LIMITED
SM.03.DTX
In Commercial Distribution

  • 05060434423757 ()
51-000089-00

  • Cardiopulmonary bypass system heating/cooling unit
Quantum Flow Sensor - ID1/8" x Wall 1/16" (OD1/4") 1.20m
SPECTRUM MEDICAL LIMITED
QFS6-ST-120
In Commercial Distribution

  • 05060434423740 ()
51-000150-00

  • Cardiopulmonary bypass system air bubble/fluid level detector
Quantum Flow Sensor - ID1/8" x Wall 1/16" (OD1/4") 2.00m
SPECTRUM MEDICAL LIMITED
QFS6-ST-200
In Commercial Distribution

  • 05060434423733 ()
51-000149-00

  • Cardiopulmonary bypass system air bubble/fluid level detector
Quantum Flow Sensor - ID1/8" x Wall 1/16" (OD1/4") 3.00m
SPECTRUM MEDICAL LIMITED
QFS6-ST-300
In Commercial Distribution

  • 05060434423726 ()
51-000148-00

  • Cardiopulmonary bypass system air bubble/fluid level detector
Quantum Flow Sensor - ID3/16" x Wall 3/32" (OD3/8") 0.75m
SPECTRUM MEDICAL LIMITED
QFS7-ST-075
In Commercial Distribution

  • 05060434423719 ()
51-000147-00

  • Cardiopulmonary bypass system air bubble/fluid level detector
Quantum Flow Sensor - ID3/16" x Wall 3/32" (OD3/8") 1.20m
SPECTRUM MEDICAL LIMITED
QFS7-ST-120
In Commercial Distribution

  • 05060434423702 ()
51-000146-00

  • Cardiopulmonary bypass system air bubble/fluid level detector
Quantum Flow Sensor - ID3/16" x Wall 3/32" (OD3/8") 2.00m
SPECTRUM MEDICAL LIMITED
QFS7-ST-200
In Commercial Distribution

  • 05060434423696 ()
51-000145-00

  • Cardiopulmonary bypass system air bubble/fluid level detector
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