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510(k) K213795

Videa Caries Assist by Videahealth, Inc. — Product Code MYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2022
Date Received
December 6, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Medical Image
Device Class
Class II
Regulation Number
892.2070
Review Panel
RA
Submission Type

For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers

Other clearances by Videahealth, Inc.

  • K251002 — Videa Dental AI (September 19, 2025)
  • K232384 — Videa Dental Assist (December 15, 2023)
  • K223296 — Videa Perio Assist (February 6, 2023)

Other clearances for product code MYN

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  • K252934 — Diagnocat (January 15, 2026)
  • K253009 — DS Core Detect (January 7, 2026)
  • K252086 — DTX Studio Assist (November 17, 2025)
  • K250525 — Second Opinion® Panoramic (November 14, 2025)
  • K250264 — SugarBug (1.x) (November 7, 2025)
  • K251002 — Videa Dental AI (September 19, 2025)
  • K250753 — VELMENI for DENTISTS (V4D) (September 2, 2025)
  • K243234 — Second Opinion® CS (June 12, 2025)
  • K242437 — Smile Dx® (May 14, 2025)