← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

MYN — Analyzer, Medical Image

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

DEVICE CLASS
Class II
REGULATION
21 CFR 892.2070
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
19
510(K)/PMA CLEARANCES
510k: 19
0
RECALL ENTRIES

Recent clearances

K260851Better Diagnostics AI Corp. · 510k2026-07-15
K252953Velmeni, Inc. · 510k2026-05-11
K251934Qure.Ai Technologies · 510k2026-01-16
K252934DGNCT, LLC · 510k2026-01-15
K253009Dentsply Sirona, Inc. · 510k2026-01-07
K252086Nobel Biocare C/O Medicim NV · 510k2025-11-17
K250525Pearl, Inc. · 510k2025-11-14
K250264Bench7, Inc. · 510k2025-11-07

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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