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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V2.1.3 Operating Software for Codonics Horizon® Imagers serial number prefix 50C, 51C, and 52C
CODONICS INC.
2.1.3
In Commercial Distribution

  • 00814905020045 ()


  • Diagnostic-imaging multiformat camera
No Description
KONICA MINOLTA, INC.
AE1T
In Commercial Distribution

  • 04560141950474 ()


  • Diagnostic-imaging multiformat camera
No Description
KONICA MINOLTA, INC.
A9R5
In Commercial Distribution

  • 04560141945647 ()


  • Diagnostic-imaging multiformat camera
No Description
KONICA MINOLTA, INC.
A9R4
In Commercial Distribution

  • 04560141945630 ()


  • Diagnostic-imaging multiformat camera
No Description
KONICA MINOLTA, INC.
A4AA
In Commercial Distribution

  • 04560141932494 ()


  • Diagnostic-imaging multiformat camera
No Description
KONICA MINOLTA, INC.
A4A9
In Commercial Distribution

  • 04560141932487 ()


  • Diagnostic-imaging multiformat camera
No Description
KONICA MINOLTA, INC.
A2MM
In Commercial Distribution

  • 04560141923126 ()


  • Diagnostic-imaging multiformat camera
No Description
KONICA MINOLTA, INC.
A2GP
In Commercial Distribution

  • 04560141923119 ()


  • Diagnostic-imaging multiformat camera
No Description
KONICA MINOLTA, INC.
GNPM
In Commercial Distribution

  • 04560141922686 ()


  • Diagnostic-imaging multiformat camera
No Description
KONICA MINOLTA, INC.
GM76
In Commercial Distribution

  • 04560141921641 ()


  • Diagnostic-imaging multiformat camera
MEDICAL DRY IMAGING FILM 100NIF 35x43
FUJIFILM CORPORATION
DI-HL 35X43 100 ==
In Commercial Distribution

  • 14547410222576 ()
  • 04547410222579 ()
  • 84547410222575 ()

  • 35X43CM
4741022257

  • Diagnostic-imaging multiformat camera
MEDICAL DRY IMAGING FILM 150NIF 20x25
FUJIFILM CORPORATION
DI-HL 20X25 150 =
In Commercial Distribution

  • 14547410222569 ()
  • 04547410222562 ()
  • 84547410222568 ()

  • 20X25CM
4741022256

  • Diagnostic-imaging multiformat camera
MEDICAL DRY IMAGING FILM 150NIF 25x30
FUJIFILM CORPORATION
DI-HL 25X30 150 =
In Commercial Distribution

  • 14547410222552 ()
  • 04547410222555 ()
  • 84547410222551 ()

  • 25X30CM
4741022255

  • Diagnostic-imaging multiformat camera
MEDICAL DRY IMAGING FILM 150NIF 26x36
FUJIFILM CORPORATION
DI-HL 26X36 150 =
In Commercial Distribution

  • 14547410222545 ()
  • 04547410222548 ()
  • 84547410222544 ()

  • 26X36CM
4741022254

  • Diagnostic-imaging multiformat camera
MEDICAL DRY IMAGING FILM 100NIF 35x43
FUJIFILM CORPORATION
DI-HL 35X43 100 =
In Commercial Distribution

  • 14547410222491 ()
  • 04547410222494 ()
  • 84547410222490 ()

  • 35X43CM
4741022249

  • Diagnostic-imaging multiformat camera
MEDICAL DRY IMAGING FILM 100NIF 35x43
FUJIFILM CORPORATION
DI-HT 35X43 100
In Commercial Distribution

  • 14547410080794 ()
  • 04547410080797 ()
  • 84547410080793 ()

  • 35X43CM
4741008079

  • Diagnostic-imaging multiformat camera
MEDICAL DRY IMAGING FILM 100NIF 26x36
FUJIFILM CORPORATION
DI-HT 26X36 100
In Commercial Distribution

  • 14547410080770 ()
  • 04547410080773 ()
  • 84547410080779 ()

  • 26X36CM
4741008077

  • Diagnostic-imaging multiformat camera
MEDICAL DRY IMAGING FILM 100NIF 35x43
FUJIFILM CORPORATION
DI-AT 35X43 100
In Commercial Distribution

  • 14547410080558 ()
  • 04547410080551 ()
  • 84547410080557 ()

  • 35X43CM
4741008055

  • Diagnostic-imaging multiformat camera
The DRYPIX Smart is a device that prints digital image data, transferred via the DICOM network from the FCR/FDR Image Reader or DR, CT, MRI and other imaging modalities, onto a film.
FUJIFILM CORPORATION
DRYPIX SMART II : E
In Commercial Distribution

  • 04547410431957 ()


  • Diagnostic-imaging multiformat camera
"The MINI DOCK USB2 module is built-in docking station for SOPROCARE, SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
MINI DOCK OWANDY-CAM HD
In Commercial Distribution

  • 03760278264920 ()
S_ODOCK_0001

  • Diagnostic-imaging multiformat camera
This is an extra- and intra-oral Sopro 617 camera designed for dental applications. It allows the user to see anatomical and pathological details that cannot be seen with the naked eye, as well as pathology control and post-treatment.
SOPRO
OWANDY-CAM HD NTSC
In Commercial Distribution

  • 03760278264913 ()
S_OCAM_0002

  • Diagnostic-imaging multiformat camera
This is an extra- and intra-oral Sopro 617 camera designed for dental applications. It allows the user to see anatomical and pathological details that cannot be seen with the naked eye, as well as pathology control and post-treatment.
SOPRO
OWANDY-CAM HD PAL
In Commercial Distribution

  • 03760278264906 ()
S_OCAM_0001

  • Diagnostic-imaging multiformat camera
Sub-Component - Product alone (without Box and accessories) "The MINI DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE and SOPROLIFE cameras. This product is designed for dental applications and is not intended for diagnosis"
SOPRO
DOCK MU USB2 ADEC 300 2M GR3
In Commercial Distribution

  • 03760278263251 ()
997096

  • Diagnostic-imaging multiformat camera
The SOPROCARE is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details that are invisible to the naked eye or with a mirror (thanks to its magnification). In CARIO mode, the camera helps the dental practitioner to highlight carious warning on pits and fissures of the occlusal side of the teeth. In DAYLIGHT mode, the camera enables you to visualize anatomical details invisible to the naked eye or with a mirror (thanks to its magnification). In PERIO mode, the camera helps the dental practitioner to see the presence of dental plaque but also to highlight gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing). This mode offers to the dentist and/or hygienist a tool for an improved communication, motivation and education of his/her patients, who will then become aware of their oral health condition.
SOPRO
SOPROCARE NTSC
In Commercial Distribution

  • 03760278262803 ()
S_950_0009

  • Diagnostic-imaging multiformat camera
"In mode I, diagnosis aid mode, SOPROLIFE helps the dental practitioner to detect damage at various clinical stages in very high resolution. In mode II, treatment aid mode, SOPROLIFE helps dental practitioner to get a spatial map of unbroken tissue areas which are suspect. In daylight mode », SOPROLIFE enables you to visualize anatomical details invisible to the naked eye or with a mirror. It allows the dentist to show the difference between «before» and «after» care."
SOPRO
SOPROLIFE NTSC
In Commercial Distribution

  • 03760278262773 ()
S_900_0009

  • Diagnostic-imaging multiformat camera
"The MINI DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE and SOPROLIFE cameras. This product is designed for dental applications and is not intended for diagnosis"
SOPRO
MINI DOCK U_USB2 5M
In Commercial Distribution

  • 03760278262650 ()
S_717_1734

  • Diagnostic-imaging multiformat camera
"The MINI DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE and SOPROLIFE cameras. This product is designed for dental applications and is not intended for diagnosis"
SOPRO
MINI DOCK U_USB2 5M
In Commercial Distribution

  • 03760278262643 ()
S_717_1733

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE and SOPROLIFE cameras. This product is designed for dental applications and is not intended for diagnosis"
SOPRO
MINI DOCK U_USB2 1.5M
In Commercial Distribution

  • 03760278262575 ()
S_717_1726

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE and SOPROLIFE cameras. This product is designed for dental applications and is not intended for diagnosis"
SOPRO
MINI DOCK U_USB2
In Commercial Distribution

  • 03760278262551 ()
S_717_1724

  • Diagnostic-imaging multiformat camera
"The MINI DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE and SOPROLIFE cameras. This product is designed for dental applications and is not intended for diagnosis"
SOPRO
MINI DOCK U_USB2 7M
In Commercial Distribution

  • 03760278262544 ()
S_717_1723

  • Diagnostic-imaging multiformat camera
"The MINI DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE and SOPROLIFE cameras. This product is designed for dental applications and is not intended for diagnosis"
SOPRO
MINI DOCK U_USB2 7M
In Commercial Distribution

  • 03760278262537 ()
S_717_1722

  • Diagnostic-imaging multiformat camera
"The MINI DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE and SOPROLIFE cameras. This product is designed for dental applications and is not intended for diagnosis"
SOPRO
MINI DOCK U_USB2 7M
In Commercial Distribution

  • 03760278262520 ()
S_717_1721

  • Diagnostic-imaging multiformat camera
"The MINI DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE and SOPROLIFE cameras. This product is designed for dental applications and is not intended for diagnosis"
SOPRO
MINI DOCK U_USB2 5M
In Commercial Distribution

  • 03760278262360 ()
S_717_1716

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE and SOPROLIFE cameras. This product is designed for dental applications and is not intended for diagnosis"
SOPRO
MINI DOCK U_USB2 5M
In Commercial Distribution

  • 03760278262353 ()
S_717_1715

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE and SOPROLIFE cameras. This product is designed for dental applications and is not intended for diagnosis"
SOPRO
MINI DOCK U_USB2 7M
In Commercial Distribution

  • 03760278262339 ()
S_717_1706

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE and SOPROLIFE cameras. This product is designed for dental applications and is not intended for diagnosis"
SOPRO
MINI DOCK U_USB2 2M
In Commercial Distribution

  • 03760278262322 ()
S_717_1703

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE and SOPROLIFE cameras. This product is designed for dental applications and is not intended for diagnosis"
SOPRO
DOCK U_USB2 5M ADEC 300
In Commercial Distribution

  • 03760278262162 ()
S_717_1514

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE and SOPROLIFE cameras. This product is designed for dental applications and is not intended for diagnosis"
SOPRO
DOCK U_USB2 5M ADEC 500
In Commercial Distribution

  • 03760278262155 ()
S_717_1513

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB BELMONT 7M BIEN AIR
In Commercial Distribution

  • 03760278262100 ()
S_717_1508

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB FEDESA 7M BIEN AIR
In Commercial Distribution

  • 03760278262094 ()
S_717_1507

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB ADEC 500 SURG 1.5M
In Commercial Distribution

  • 03760278262087 ()
S_717_1506

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB ADEC 300 7M GR3
In Commercial Distribution

  • 03760278262063 ()
S_717_1504

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB ADEC 300 2M GR3
In Commercial Distribution

  • 03760278262056 ()
S_717_1503

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB ADEC 500 7M SF6
In Commercial Distribution

  • 03760278262049 ()
S_717_1502

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB ADEC 500 2M SF6
In Commercial Distribution

  • 03760278262032 ()
S_717_1501

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE and SOPROLIFE cameras. This product is designed for dental applications and is not intended for diagnosis"
SOPRO
CONTROLLER - USB2 - 2.5M
In Commercial Distribution

  • 03760278261998 ()
S_717_1087

  • Diagnostic-imaging multiformat camera
"The DOCK MU_VIDEO module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE and SOPROLIFE cameras. This product is designed for dental applications and is not intended for diagnosis"
SOPRO
54.0293.00 DOCK ANALOG 2M G3
In Commercial Distribution

  • 03760278261981 ()
S_717_1079

  • Diagnostic-imaging multiformat camera
"The DOCK MU_VIDEO module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE and SOPROLIFE cameras. This product is designed for dental applications and is not intended for diagnosis"
SOPRO
54.0310.00 DOCK ANALOG 2M G3
In Commercial Distribution

  • 03760278261974 ()
S_717_1078

  • Diagnostic-imaging multiformat camera
"The DOCK MU_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE and SOPROLIFE cameras. This product is designed for dental applications and is not intended for diagnosis"
SOPRO
DOCK MU USB2 ADEC 300 2M GR3
In Commercial Distribution

  • 03760278261967 ()
S_717_1076

  • Diagnostic-imaging multiformat camera
"The DOCK M_VIDEO module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE and SOPROLIFE cameras. This product is designed for dental applications and is not intended for diagnosis"
SOPRO
CONTROLLER - VIDEO - 2.5M
In Commercial Distribution

  • 03760278261950 ()
S_717_1075

  • Diagnostic-imaging multiformat camera
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