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510(k) K133422

1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE by Neocoil, LLC — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 2013
Date Received
November 8, 2013
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coil, Magnetic Resonance, Specialty
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

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  • K123272 — 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM (March 28, 2013)

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  • K243675 — InkSpace Imaging Small Body Array (December 20, 2024)
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