510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K061281Substantially Equivalent

Insight Head Coil

Insight Neuroimaging Systems, LLC, Worchester MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061281 is the FDA 510(k) clearance record for INSIGHT HEAD COIL, a class II device, cleared for Insight Neuroimaging Systems, LLC on under FDA product code MOS (Coil, Magnetic Resonance, Specialty). FDA records list one 510(k) clearance for Insight Neuroimaging Systems, LLC. As of , FDA records show no recalls naming K061281.

Clearance record

Decision date
Received
(42 days to decision)
Product code
MOS Coil, Magnetic Resonance, Specialty
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Insight Neuroimaging Systems, LLC 11 Canterbury St., Worchester MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MOS

Trailing 12 months
9 clearances under product code MOS in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MOS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20261
March 20261
April 20263
May 20260
June 20260
July 20262
August 20260
September 20260
October 20260