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510(k) K160240

Perimeter Otis™ 1.0 Optical Coherence Tomography System by Perimeter Medical Imaging, Inc. — Product Code NQQ

Clearance Details

Decision
SESU ()
Decision Date
May 13, 2016
Date Received
February 1, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Optical Coherence Tomography (Oct)
Device Class
Class II
Regulation Number
892.1560
Review Panel
SU
Submission Type

This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.

Other clearances by Perimeter Medical Imaging, Inc.

  • K190404 — OTIS Optical Coherence Tomography SYstem (March 26, 2019)
  • K171560 — OTIS Optical Coherence Tomography System (August 25, 2017)

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