510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211658Substantially Equivalent

OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T

NORAS MRI products GmbH, Hoechberg, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211658 is the FDA 510(k) clearance record for OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T, a class II device, cleared for Noras Mri Products GmbH on under FDA product code MOS (Coil, Magnetic Resonance, Specialty). FDA records list 10 510(k) clearances for Noras Mri Products GmbH, from to . As of , FDA records show no recalls naming K211658.

Clearance record

Decision date
Received
(279 days to decision)
Product code
MOS Coil, Magnetic Resonance, Specialty
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Noras Mri Products GmbH Leibnizstr. 4, Hoechberg, DE
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