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510(k) K201552

ApolloVue S100 Image System by Apollo Medical Optics, Ltd. — Product Code NQQ

K201552 is an FDA 510(k) premarket notification submitted by Apollo Medical Optics, Ltd. for the device "ApolloVue S100 Image System". The FDA issued a decision of Substantially Equivalent on September 2, 2020. 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
September 2, 2020
Date Received
June 10, 2020
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.

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  • K250684 — OPUSWAVE Dual Sensor Imaging System (July 2, 2025)
  • K242924 — OPXION Optical Skin Viewer (OPXSV1-01F) (June 23, 2025)
  • K242098 — Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging Sy (April 11, 2025)
  • K243016 — Starlight Imaging Catheter (March 20, 2025)
  • K242239 — HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), (August 16, 2024)

FDA data resources