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510(k) K243234

Second Opinion® CS by Pearl, Inc. — Product Code MYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2025
Date Received
October 10, 2024
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 Pearl, Inc.

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  • K243989 — Second Opinion® 3D (May 23, 2025)
  • K243230 — Second Opinion® BLE (May 9, 2025)
  • K243893 — Second Opinion® Pediatric (May 5, 2025)
  • K242600 — Second Opinion Periapical Radiolucency Contours (April 11, 2025)
  • K242522 — Second Opinion CC (January 16, 2025)
  • K210365 — Second Opinion (March 4, 2022)

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)
  • K242437 — Smile Dx® (May 14, 2025)
  • K243893 — Second Opinion® Pediatric (May 5, 2025)