510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MYNClass II

Analyzer, Medical Image

21 CFR 892.2070 / Radiology
FDA source (opens on fda.gov)

MYN is the FDA product code for Analyzer, Medical Image, a class II device type, regulated under 21 CFR 892.2070. FDA's definition for this code reads: "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". As of , FDA records hold 39 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
MYN
Device name
Analyzer, Medical Image
FDA 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
Regulation
21 CFR 892.2070
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
40
Ingested recalls
3

Clearances, product code MYN

By decision year
40 clearances under product code MYN with a decision year between 2021 and 2026, 2025 the highest year at 14.
Show the numbers
510(k) clearances under FDA product code MYN by decision year
YearClearances
20212
20225
202310
20242
202514
20267

Applicants with the most clearances

Product code MYN
Applicants holding the most 510(k) clearances under product code MYN
ApplicantClearances
Overjet6
Pearl, Inc.6
Imagen Technologies, Inc.4
Velmeni3
VideaHealth, Inc.3
Better Diagnostics AI Corp2
Qure.ai Technologies Inc2
AZmed1
BENCH7, Inc1
Cube Click, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order