Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T— 510(k) K220144

Name: FDA 510(k) clearance K220144
Creator: U.S. Food and Drug Administration
Published: 2022-04-08

Substantially Equivalent

Noras Mri Products GmbH

FDA 510(k) clearance K220144 for Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T, Substantially Equivalent on 2022-04-08. Applicant: Noras Mri Products GmbH. Device class: 2.

Clearance details

Applicant: Noras Mri Products GmbH
Product code: Code MOS
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2022-01-19
Decision date: 2022-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Höchberg, DE

Download summary PDF View on FDA.gov ↗

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K180123 — Breast BI 7 MR Coil 1.5T Mammavention2018-02-16
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