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FDA 510(k)

3.0T 16ch Breast Coil

K-Number: K173377 · 2017-11-28

ApplicantNeocoil, LLC
Decision Date2017-11-28
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3.0T 16ch Breast Coil is a medical device manufactured by Neocoil, LLC. It received FDA 510(k) clearance on 2017-11-28 under approval number K173377. 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 3.0T 16ch Breast Coil?

3.0T 16ch Breast Coil is a medical device that received FDA 510(k) clearance on 2017-11-28. It is manufactured by Neocoil, LLC. The 510(k) number is K173377.

When was 3.0T 16ch Breast Coil approved by the FDA?

3.0T 16ch Breast Coil received FDA 510(k) clearance on 2017-11-28, under approval number K173377.

What company makes 3.0T 16ch Breast Coil?

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

What is the FDA product code for 3.0T 16ch Breast Coil?

The FDA product code for 3.0T 16ch Breast Coil is MOS.

Other Devices by Neocoil, LLC

K160350ECG CT Gating Device K1829581.5T 16ch Breast Coil K173409Wireless Audio System K2011011.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil 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

View all 8 devices →

Related Devices (Code: MOS)

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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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