1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil— 510(k) K181948

Clearance details

Applicant

Rapid Biomedical GmbH

Product code

Code MOS

Device class

Class 2

Regulation

21 CFR 892.1000

Advisory panel

Radiology

Date received

2018-07-20

Decision date

2018-11-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Rimpar, DE

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