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FDA 510(k)

1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil

K-Number: K201101 · 2020-06-02

ApplicantNeocoil, LLC
Decision Date2020-06-02
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil is a medical device manufactured by Neocoil, LLC. It received FDA 510(k) clearance on 2020-06-02 under approval number K201101. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil?

1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil is a medical device that received FDA 510(k) clearance on 2020-06-02. It is manufactured by Neocoil, LLC. The 510(k) number is K201101.

When was 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil approved by the FDA?

1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil received FDA 510(k) clearance on 2020-06-02, under approval number K201101.

What company makes 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil?

1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil is manufactured by Neocoil, LLC.

What is the FDA product code for 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil?

The FDA product code for 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil is MOS.

Other Devices by Neocoil, LLC

K160350ECG CT Gating Device K1733773.0T 16ch Breast Coil K1829581.5T 16ch Breast Coil K173409Wireless Audio System K22240716ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil K21368732Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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