0.55T 12Ch Breast Coil— 510(k) K260947

Clearance details

Applicant

Neocoil, LLC

Product code

Code MOS

Device class

Class 2

Regulation

21 CFR 892.1000

Advisory panel

Radiology

Date received

2026-03-23

Decision date

2026-04-23

Decision

Substantially Equivalent

Clearance type

Special

Location

Pewaukee, WI, US

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