FDA 510(k)

0.55T 12Ch Breast Coil

K-Number: K260947 · 2026-04-23

Decision Date2026-04-23

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

0.55T 12Ch Breast Coil is a medical device manufactured by Neocoil, LLC. It received FDA 510(k) clearance on 2026-04-23 under approval number K260947. 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 0.55T 12Ch Breast Coil?

0.55T 12Ch Breast Coil is a medical device that received FDA 510(k) clearance on 2026-04-23. It is manufactured by Neocoil, LLC. The 510(k) number is K260947.

When was 0.55T 12Ch Breast Coil approved by the FDA?

0.55T 12Ch Breast Coil received FDA 510(k) clearance on 2026-04-23, under approval number K260947.

What company makes 0.55T 12Ch Breast Coil?

0.55T 12Ch Breast Coil is manufactured by Neocoil, LLC.

What is the FDA product code for 0.55T 12Ch Breast Coil?

The FDA product code for 0.55T 12Ch Breast Coil is 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.