DeviceClearance

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

Substantially Equivalent

Rapid Biomedical GmbH

FDA 510(k) clearance K181948 for 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil, Substantially Equivalent on 2018-11-16. Applicant: Rapid Biomedical GmbH.

Clearance details

Applicant
Rapid Biomedical GmbH
Product code
Code MOS
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rimpar, DE
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.