Analyzer, Medical Image

MYN · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.2070

Classification

FDA Product Code: MYN
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 892.2070
Review panel: RA
Medical specialty: Radiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

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

Market data

Cleared 510(k) submissions: 36
Registered establishments: 28

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown