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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X-MIND trium PAN_CEPH version including one removable ceph sensor, with control panel on the left and ceph arm on the right configurated for installation of CBCT sensor
DE GÖTZEN SRL
XMT PAN R CEPH L 3D READY
Not in Commercial Distribution

  • D804W09002390 ()
W0900239

  • Stationary panoramic/tomographic dental x-ray system, digital
X-MIND trium PAN CBCT CEPH version including one PAN sensor,with control panel on the right side including one removable ceph sensor ceph arm on the right
DE GÖTZEN SRL
XMT PAN 3D R CEPH R
Not in Commercial Distribution

  • D804W09002310 ()
W0900231

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
X-MIND trium PAN CBCT CEPH version including one PAN sensor, with control panel on the right side including one removable ceph sensor ceph arm on the left
DE GÖTZEN SRL
XMT PAN 3D R CEPH L
Not in Commercial Distribution

  • D804W09000060 ()
W0900006

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware
MESA BIOTECH, INC.
D2001
In Commercial Distribution

  • B540D20010 ()
D2001

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
The Accula Dock is an electronic module which executes in vitro diagnostic tests on compatible Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to orchestrate in-vitro diagnostic tests within the inserted Test Cassette.
MESA BIOTECH, INC.
D2000
In Commercial Distribution

  • B540D20000 ()
D2000

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
X-MIND trium PAN version including one PAN sensor, with control panel on the left side including one removable ceph sensor configurated for installation of ceph arm on the right
DE GÖTZEN SRL
XMT PAN L CEPH READY R
Not in Commercial Distribution

  • D804W09000080 ()
W0900008

  • Stationary panoramic/tomographic dental x-ray system, digital
X-MIND trium PAN version including one PAN sensor, with control panel on the right side including one removable ceph sensor configurated for installation of ceph arm on the left
DE GÖTZEN SRL
XMT PAN R CEPH READY L
Not in Commercial Distribution

  • D804W09000020 ()
W0900002

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
X-MIND trium PAN CBCT version including one PAN sensor,with control panel on the left side including one removable ceph sensor configurated for installation of ceph arm on the right
DE GÖTZEN SRL
XMT PAN 3D L CEPH READY R (PAN SENSOR)
Not in Commercial Distribution

  • D804W09000560 ()
W0900056

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
X-MIND trium PAN CBCT version including one PAN sensor,with control panel on the right side including one removable ceph sensor configurated for installation of ceph arm on the left
DE GÖTZEN SRL
XMT PAN 3D R CEPH READY L (PAN SENSOR)
Not in Commercial Distribution

  • D804W09000550 ()
W0900055

  • Stationary panoramic/tomographic dental x-ray system, digital
  • Cone beam computed tomography system, head/neck
X-MIND trium PAN CBCT version including one CEPH sensor,with control panel on the left side including one removable ceph sensor configurated for installation of ceph arm on the right
DE GÖTZEN SRL
XMT PAN 3D L CEPH READY R
Not in Commercial Distribution

  • D804W09000110 ()
W0900011

  • Stationary panoramic/tomographic dental x-ray system, digital
  • Cone beam computed tomography system, head/neck
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