510(k) · Cleared
ClearedNoras or Head Holder Flexibility
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Noras Mri Products GmbH · MOS Coil, Magnetic Resonance, Specialty
Cleared on Aug 6, 2014 as substantially equivalent to K071179 (Siemens Medical Solutions USA, Inc., 2007) after a 265-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Aug 6, 2014
- Review
- 265 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K012495 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK012495 OR Table and Headholder/Magnetom Harmony, Symphony, Sonata SystemsSiemens Medical Solutions USA, Inc. · 2001 · Recalled
- 1 generation backK071179 Noras or Head HolderSiemens Medical Solutions USA, Inc. · 2007
- This deviceK133506 Noras or Head Holder FlexibilityNoras Mri Products GmbH · 2014
- Descendant · cites it directly · 0 of its ownK211658 OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder…Noras Mri Products GmbH · 2022
Most influential descendants
Showing 1 of 1 · See all- K211658OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet…Noras Mri Products GmbH · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K012495 | OR Table and Headholder/Magnetom Harmony, Symphony, Sonata Systems | Siemens Medical Solutions USA, Inc. | 2001 | 1 |
| −1 | K071179 | Noras or Head Holder | Siemens Medical Solutions USA, Inc. | 2007 | — |
| 0 (this device) | K133506 | Noras or Head Holder Flexibility | Noras Mri Products GmbH | 2014 | — |
| +1 | K211658 | OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with… | Noras Mri Products GmbH | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
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 K253738 3.0T Air 32CH Hnascore 15.2 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071179 | Noras or Head HolderSummary page 8…equivalent to the following OR Head Holder: Predicate 510(k) Clearance Product | Comparable Device Name Number Date Code Properties and Manufacturer NORAS OR Head | K071179 April 27-2007 | MOS, HBL Fixation of the Holder patient’'s head 003_Summary.docx Page 4 of 5 003_Summary.docx N… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211658 | OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet… | 2022 | 0 |
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 13 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K211658 (Noras Mri Products GmbH, 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K071179.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 2025
MAUDE reports naming product code MOS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 19 | 0 | 4 |
| 2008 | 19 | 33 | 2 | 2 |
| 2009 | 10 | 43 | 0 | 5 |
| 2010 | 16 | 78 | 1 | 13 |
| 2011 | 25 | 57 | 0 | 7 |
| 2012 | 15 | 49 | 1 | 12 |
| 2013 | 7 | 87 | 0 | 10 |
| 2014 | 12 | 60 | 0 | 4 |
| 2015 | 6 | 58 | 2 | 5 |
| 2016 | 11 | 42 | 0 | 7 |
| 2017 | 9 | 63 | 0 | 9 |
| 2018 | 10 | 30 | 0 | 7 |
| 2019 | 3 | 178 | 8 | 8 |
| 2020 | 5 | 51 | 1 | 2 |
| 2021 | 4 | 41 | 0 | 3 |
| 2022 | 11 | 79 | 0 | 5 |
| 2023 | 10 | 59 | 0 | 4 |
| 2024 | 10 | 39 | 13 | 8 |
| 2025 | 3 | 59 | 0 | 2 |
| 2026 | 10 | 45 | 0 | — |
What is it indicated for?
For Siemens: The NORAS OR Head Holder Flexibility and the NORAS OR Head Coils 1.5T / 3.0T are used for intra-operative MR imaging during open-skull neurosurgery. The NORAS OR Head Holder is used for safely securing the patient’s head during the intervention. The NORAS OR Head Holder Flexibility together with the NORAS OR Head Coil 1.5T / 3.0T are suitable for use with the MR system MAGNETOM Aera / Skyra and the Combi-Dockable-Table together with Trumpf…
Read the full statement (177 words)
For Siemens:
The NORAS OR Head Holder Flexibility and the NORAS OR Head Coils 1.5T / 3.0T are used for intra-operative MR imaging during open-skull neurosurgery.
The NORAS OR Head Holder is used for safely securing the patient’s head during the intervention.
The NORAS OR Head Holder Flexibility together with the NORAS OR Head Coil 1.5T / 3.0T are suitable for use with the MR system MAGNETOM Aera / Skyra and the Combi-Dockable-Table together with Trumpf OR Tables TrueSystem 7500 (EU/US Version) and as well as together with Maquet OR Tables Magnus (EU/US Version) and Alpha Maquet Plus (EU/US Version).
For Philips:
The NORAS OR Head Holder Flexibility and the NORAS OR Head Coils 1.5T / 3.0T are used for intra-operative MR imaging during open-skull neurosurgery.
The NORAS OR Head Holder is used for safely securing the patient’s head during the intervention.
The NORAS OR Head Holder Flexibility together with the NORAS OR Head Coil 1.5T / 3.0T are suitable for Philips MR system Ingenia 1.5T/3T in combination with Maquet Transfer Board together with Maquet OR table.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K133506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133506: Noras or Head Holder Flexibility.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133506
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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