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510(k) K251002

Videa Dental AI by Videahealth, Inc. — Product Code MYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2025
Date Received
April 1, 2025
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.

  • K232384 — Videa Dental Assist (December 15, 2023)
  • K223296 — Videa Perio Assist (February 6, 2023)
  • K213795 — Videa Caries Assist (April 21, 2022)

Other clearances for product code MYN

  • K251934 — qXR-Detect (January 16, 2026)
  • 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)
  • K250753 — VELMENI for DENTISTS (V4D) (September 2, 2025)
  • K243234 — Second Opinion® CS (June 12, 2025)
  • K242437 — Smile Dx® (May 14, 2025)
  • K243893 — Second Opinion® Pediatric (May 5, 2025)