1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM— 510(k) K123272

Name: FDA 510(k) clearance K123272
Creator: U.S. Food and Drug Administration
Published: 2013-03-28

Substantially Equivalent

Neocoil, LLC

FDA 510(k) clearance K123272 for 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM, Substantially Equivalent on 2013-03-28. Applicant: Neocoil, LLC. Device class: 2.

Clearance details

Applicant: Neocoil, LLC
Product code: Code MOS
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2012-10-19
Decision date: 2013-03-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Pewaukee, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MOS

view all

K262330 — dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T2026-07-30
K262294 — dS FootAnkle 16Ch 1.5T +5 more2026-07-24
K260947 — 0.55T 12Ch Breast Coil2026-04-23
K252587 — HD 8Ch Wrist Array2026-04-14
K252876 — GEM Flex Coil 16-L Array, 3.0T Receive Only +2 more2026-04-01

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 Coil2022-10-14
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 16ch2022-03-11
K201101 — 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil2020-06-02
K182958 — 1.5T 16ch Breast Coil2018-11-16
K173409 — Wireless Audio System2018-02-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.