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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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The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest. Perimeter’s OTIS 2.1 cart assembly encloses an OCT-based imaging system and has a touchscreen monitor.
Perimeter Medical Imaging AI, Inc.
PMI001OCT21
In Commercial Distribution

  • 00754016215049 ()
  • 10754016215046 ()
ASY-2000

  • Dermatological optical coherence tomography system
The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest. Perimeter’s OTIS 2.1 cart assembly encloses an OCT-based imaging system and has a touchscreen monitor.
Perimeter Medical Imaging AI, Inc.
PMI001OCT21
In Commercial Distribution

  • 00754016215018 ()
  • 10754016215015 ()
ASY-2000

  • Dermatological optical coherence tomography system
The OTIS 2.1 system includes a single-use specimen container, the Consumable Set, that facilitates tissue imaging. The consumable set consists of a Specimen Tray and Specimen Lid. The Specimen Tray engages with the device to initiate scanning and the Specimen Lid facilitates engaging vacuum to enable vacuum assisted specimen positioning during image acquisition.
Perimeter Medical Imaging AI, Inc.
PMI010CON21
In Commercial Distribution

  • 20754016215029 ()
  • 00754016215025 ()
  • 00754016215032 ()
ASY-2600

  • Dermatological optical coherence tomography system
No Description
Brainlab AG
53237-10
Not in Commercial Distribution

  • 04056481141783 ()


  • Robotic surgical navigation system
No Description
Brainlab AG
53205
Not in Commercial Distribution

  • 04056481138912 ()
53205

  • Robotic surgical navigation system
No Description
Brainlab AG
53238A
Not in Commercial Distribution

  • 04056481138738 ()
53238A

  • Robotic surgical navigation system
No Description
Brainlab AG
53237A
Not in Commercial Distribution

  • 04056481138721 ()
53237A

  • Robotic surgical navigation system
No Description
Brainlab AG
41836
Not in Commercial Distribution

  • 04056481006198 ()
41836

  • Robotic surgical navigation system
No Description
Brainlab AG
52782
Not in Commercial Distribution

  • 04056481005771 ()
52782

  • Robotic surgical navigation system
No Description
Brainlab AG
52866
Not in Commercial Distribution

  • 04056481005719 ()
52866

  • Robotic surgical navigation system
No Description
Brainlab AG
53201
Not in Commercial Distribution

  • 04056481005627 ()
53201

  • Robotic surgical navigation system
No Description
Brainlab AG
53202
Not in Commercial Distribution

  • 04056481005610 ()
53202

  • Robotic surgical navigation system
No Description
Brainlab AG
53203
Not in Commercial Distribution

  • 04056481005603 ()
53203

  • Robotic surgical navigation system
No Description
Brainlab AG
53204
Not in Commercial Distribution

  • 04056481005597 ()
53204

  • Robotic surgical navigation system
No Description
Brainlab AG
55085
Not in Commercial Distribution

  • 04056481005368 ()
55085

  • Robotic surgical navigation system
No Description
Brainlab AG
41879-03
Not in Commercial Distribution

  • 04056481002671 ()
41879-03

  • Robotic surgical navigation system
No Description
Brainlab AG
52400-01A
Not in Commercial Distribution

  • 04056481002411 ()
52400-01A

  • Robotic surgical navigation system
No Description
Brainlab AG
52781-10
Not in Commercial Distribution

  • 04056481002169 ()
52781-10

  • Robotic surgical navigation system
No Description
Brainlab AG
52782-10
Not in Commercial Distribution

  • 04056481002145 ()
52782-10

  • Robotic surgical navigation system
No Description
Brainlab AG
52873-01
Not in Commercial Distribution

  • 04056481001896 ()
52873-01

  • Robotic surgical navigation system
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