Home / 510(k) Clearances / K223811

510(k) K223811

Lung-CAD by Imagen Technologies, Inc. — Product Code MYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2023
Date Received
December 20, 2022
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 Imagen Technologies, Inc.

  • K230085 — Lung-CAD (October 3, 2023)
  • K213353 — Aorta-CAD (September 20, 2022)
  • K210666 — Chest-CAD (July 20, 2021)
  • K193417 — FractureDetect (FX) (July 30, 2020)
  • DEN180005 — OsteoDetect (May 24, 2018)

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)
  • 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)