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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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SeeFactor CT3 - 86000594161101

SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquires sequences of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibular joint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and upper and lower extremities for use in diagnostic support. The device displays two and three dimensional images for each examined anatomical region. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
Epica Medical Innovations LLC
9801101000
Not in Commercial Distribution

  • 86000594161101 ()
86000594161101

  • Cone beam computed tomography system, head/neck

AVIEW CAC - 08800025300367

No Description
CORELINE SOFT CO.,LTD.
2.0
In Commercial Distribution

  • 08800025300367 ()


  • Radiological PACS software

AVIEW - 08800025300299

No Description
CORELINE SOFT CO.,LTD.
2.0
In Commercial Distribution

  • 08800025300299 ()


  • Radiological PACS software

AVIEW CAC - 08800025300237

No Description
CORELINE SOFT CO.,LTD.
1.1
In Commercial Distribution

  • 08800025300237 ()


  • Radiological PACS software

AVIEW - 08800025300152

No Description
CORELINE SOFT CO.,LTD.
1.1
In Commercial Distribution

  • 08800025300152 ()


  • Radiological PACS software

AVIEW LCS - 08800025300084

No Description
CORELINE SOFT CO.,LTD.
1.1
In Commercial Distribution

  • 08800025300084 ()


  • Radiological PACS software

AVIEW - 08800025300077

No Description
CORELINE SOFT CO.,LTD.
1.1
In Commercial Distribution

  • 08800025300077 ()


  • Radiological PACS software

AVIEW LCS - 08800025300039

No Description
CORELINE SOFT CO.,LTD.
1.0
In Commercial Distribution

  • 08800025300039 ()


  • Radiological PACS software

Monarch™ Cart Software v4.1.1 - 10810068811503

Monarch™ Cart Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811503 ()


  • Robotic surgical system application software

Monarch Platform, Bronchoscopy 4.1 - 10810068810988

The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.
AURIS HEALTH, INC.
MON-000008
In Commercial Distribution

  • 20810068810985 ()
  • 10810068810988 ()


  • Robotic surgical arm system
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