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510(k) K203578

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System by Perimeter Medical Imaging Ai, Inc. — Product Code NQQ

K203578 is an FDA 510(k) premarket notification submitted by Perimeter Medical Imaging Ai, Inc. for the device "OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System". The FDA issued a decision of Substantially Equivalent on February 25, 2021. The device falls under product code NQQ (System, Imaging, Optical Coherence Tomography (Oct)), a Class II device regulated under 21 CFR 892.1560.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2021
Date Received
December 7, 2020
Clearance Type
Special
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.

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FDA data resources