510(k) Report

510(k) · Cleared

Cleared

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

K211658510(k) TraditionalCleared Mar 3, 2022279-day reviewClass II21 CFR 892.1000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Noras Mri Products GmbH · MOS Coil, Magnetic Resonance, Specialty

Cleared on Mar 3, 2022 as substantially equivalent to K133506 (Noras Mri Products GmbH, 2014) and 1 other predicate after a 279-day review. Its family tree reaches back 3 generations to 2005.

Decided
Mar 3, 2022
Review
279 days
Class
Class II
Product code
MOS
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K050319 (2005). 7 ancestors in all, the oldest K012495 (2001). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2014: 1 other ancestor2007: 1 other ancestor2005: 1 other ancestor2001: 1 other ancestorReference device: K060758 · OR Head Coil 1.5 T · Siemens Medical Solutions USA, Inc. · 2006Reference device: K091546 · Noras or Head Coil 3T, Models SI7200/SI72100/SI7220/SI7230 · Noras Mri Products GmbH · 2009K050319 · Mayfield MR/CT Skull Clamp, Model 4-0-a-1104 · Integra Lifesciences Corp. · 2005K090506 · Mayfield Infinity XR2 Skull Clamp, Model a-2114 · Integra LifeSciences Corporation · 2009K130389 · Mayfield Infinity XR2 Skull Clamp · Integra LifeSciences Corporation · 201320002005201020152020
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 2 other ancestors K130389 · Mayfield Infinity XR2 Skull Clamp · Integra LifeSciences Corporation · 2013K090506 · Mayfield Infinity XR2 Skull Clamp, Model a-2114 · Integra LifeSciences Corporation · 2009K050319 · Mayfield MR/CT Skull Clamp, Model 4-0-a-1104 · Integra Lifesciences Corp. · 20050
  1. Root · 3 generations backK050319 Mayfield MR/CT Skull Clamp, Model 4-0-a-1104Integra Lifesciences Corp. · 2005
  2. 2 generations backK090506 Mayfield Infinity XR2 Skull Clamp, Model a-2114Integra LifeSciences Corporation · 2009
  3. 1 generation backK130389 Mayfield Infinity XR2 Skull ClampIntegra LifeSciences Corporation · 2013
  4. This deviceK211658 OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder…Noras Mri Products GmbH · 2022
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K050319Mayfield MR/CT Skull Clamp, Model 4-0-a-1104Integra Lifesciences Corp.2005—
−2K090506Mayfield Infinity XR2 Skull Clamp, Model a-2114Integra LifeSciences Corporation2009—
−1K130389Mayfield Infinity XR2 Skull ClampIntegra LifeSciences Corporation2013—
0 (this device)K211658OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with…Noras Mri Products GmbH2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200510
200710
201410
FIG. 1 — Lineage of K211658, 2005–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MOS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MOS device

  1. #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K133506Noras or Head Holder Flexibility
Summary page 7
…510(k) Clearance Product Comparable Name and Number Date Code Properties Manufacturer NORAS OR Head K133506 August 6, MOS; HBL Fixation of the Holder Flexibility 2014 patient´s head…
Noras Mri Products GmbH2014—
*K130389Mayfield Infinity XR2 Skull Clamp
Summary page 7
…6, MOS; HBL Fixation of the Holder Flexibility 2014 patient´s head NORAS MRI products GmbH MAYFIELD@ Infinity K130389 April 23, 2013 HBL Fixation of the XR2 Skull Clamp patient´s head…
Integra LifeSciences Corporation2013—
†K060758OR Head Coil 1.5 TSiemens Medical Solutions USA, Inc.2006—
†K091546Noras or Head Coil 3T, Models SI7200/SI72100/SI7220/SI7230Noras Mri Products GmbH2009—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
  • 1 of the 7 ancestors has a recall of any class.

How does its category compare?

All MOS devices

MOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · MOS

3in 2025

2007: 162008: 192009: 102010: 162011: 252012: 152013: 72014: 122015: 62016: 112017: 92018: 102019: 32020: 52021: 42022: 112023: 102024: 102025: 32026 (partial year): 10
2007high 25 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOS

59in 2025

2007: 19 days median2008: 33 days median2009: 43 days median2010: 78 days median2011: 57 days median2012: 49 days median2013: 87 days median2014: 60 days median2015: 58 days median2016: 42 days median2017: 63 days median2018: 30 days median2019: 178 days median2020: 51 days median2021: 41 days median2022: 79 days median2023: 59 days median2024: 39 days median2025: 59 days median2026 (partial year): 45 days median
2007high 178 (2019) · low 19 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MOS

13in 2024

2008: 22010: 12012: 12015: 22019: 82020: 12024: 13
2007high 13 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MOS

2in 2025

2007: 42008: 22009: 52010: 132011: 72012: 122013: 102014: 42015: 52016: 72017: 92018: 72019: 82020: 22021: 32022: 52023: 42024: 82025: 2
2007high 13 (2010) · low 2 (2008)2025

MAUDE reports naming product code MOS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007161904
2008193322
2009104305
20101678113
2011255707
20121549112
2013787010
2014126004
201565825
2016114207
201796309
2018103007
2019317888
202055112
202144103
2022117905
2023105904
20241039138
202535902
202610450—

What is it indicated for?

The intended medical use of the OR Head Holder LUCY and Head Coil Set 1.5T/3T is, in conjunction with a Magnetic Resonance Scanner, intra-operative MR imaging during an open-skull neurosurgery.

The OR Head Holder LUCY is used for safe securing the patient's head during a surgical intervention at the head. It is possible to make an intraoperative assessment during the intervention to determine its progress. In the MR area the Head Coils enable the diagnostic imaging. Using Computed Tomography or C-arm Fluoroscopy, it is mandatory to remove the Head Coils and the device serves as a skull clamp only.

Indications for use as stated in the FDA summary.

More from Noras Mri Products GmbH

10 FDA decisions under this applicant name. See the company

  • K241069iLoop Interventional Coil 0.55TNoras Mri Products GmbH · 2024
  • K220144Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3TNoras Mri Products GmbH · 2022
  • K180123Breast BI 7 MR Coil 1.5T MammaventionNoras Mri Products GmbH · 2018
  • K133506Noras or Head Holder FlexibilityNoras Mri Products GmbH · 2014
  • K093693Noras or Head Holder S17000-MQ/ Noras or Head Coil 3T 7230-PH Model S1700-MQ/ 7230-PHNoras Mri Products GmbH · 2010

Recent decisions in MOS

The MOS category page

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  • K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS…Philips Medical Systems Nederland B.V. · 2026
  • K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS…Philips Medical Systems Nederland B.V. · 2026
  • K2609470.55T 12Ch Breast CoilNeocoil, LLC · 2026
  • K252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd. · 2026

https://510kreport.com/device/K211658 · printed Nov 6, 2026

Cite this page

510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211658

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026