Cleared Traditional

K211658 - 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 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211658 · Noras Mri Products GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
279d
Days
Class 2
Risk

K211658 is an FDA 510(k) clearance for the OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with H.... Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Noras Mri Products GmbH (Hoechberg, DE). The FDA issued a Cleared decision on March 3, 2022 after a review of 279 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Noras Mri Products GmbH devices

Submission Details

510(k) Number K211658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2021
Decision Date March 03, 2022
Days to Decision 279 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 107d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MOS Coil, Magnetic Resonance, Specialty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MOS Coil, Magnetic Resonance, Specialty

All 487
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K211658.
0.55T 12Ch Breast Coil
K260947 · Neocoil, LLC · Apr 2026
HD 8Ch Wrist Array
K252587 · Shenzhen RF Tech Co., Ltd. · Apr 2026
GEM Flex Coil 16-L Array, 3.0T Receive Only
K252876 · Shenzhen RF Tech Co., Ltd. · Apr 2026
Smart Fit TorsoCardiac 1.5T
K260519 · Philips Healthcare (Suzhou) Co., Ltd. · Mar 2026
GEM Flex Coil 16-L Array, 1.5T Receive Only
K252179 · Shenzhen RF Tech Co., Ltd. · Feb 2026
3.0T AIR 32CH HNA
K253738 · Ge Healthcare Coils (Usa Instruments, Inc.) · Jan 2026