0.55T 12Ch Breast Coil— 510(k) K260947
Substantially EquivalentNeocoil, LLC
FDA 510(k) clearance K260947 for 0.55T 12Ch Breast Coil, Substantially Equivalent on 2026-04-23. Applicant: Neocoil, LLC. Device class: 2.
Summary
Neocoil's 0.55T 12Ch Breast Coil is filed under product code MOS (Coil, Magnetic Resonance, Specialty).
Class II, 21 CFR 892.1000. It came in as a Special 510(k), and Radiology is both the classification panel and the review panel.
Neocoil filed from Pewaukee, Wisconsin. Review took 31 calendar days (March 23 to April 23, 2026).
Clearance details
- Applicant
- Neocoil, LLC
- Product code
- Product code MOS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Pewaukee, WI, US
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- K262294 — dS FootAnkle 16Ch 1.5T +5 more
- K252587 — HD 8Ch Wrist Array
- K252876 — GEM Flex Coil 16-L Array, 3.0T Receive Only +2 more
More clearances from Neocoil, LLC
view all- K222407 — 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil
- K213687 — 32Ch 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
- K201101 — 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil
- K182958 — 1.5T 16ch Breast Coil
- K173409 — Wireless Audio System
Data sourced from openFDA. This site is unofficial and independent of the FDA.