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Analyzer, Medical Image

FDA product code MYN · 40 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.2070
Review panel
RA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2021-07-20 – 2026-09-09

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

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