510(k) · Cleared
ClearedNoras or Head Holder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jun 13, 2007 as substantially equivalent to K012495 (Siemens Medical Solutions USA, Inc., 2001) after a 47-day review. Its family tree reaches back 1 generation to 2001. 6 later devices descend from it.
- Decided
- Jun 13, 2007
- Review
- 47 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K012495 (2001). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK012495 OR Table and Headholder/Magnetom Harmony, Symphony, Sonata SystemsSiemens Medical Solutions USA, Inc. · 2001 · Recalled
- This deviceK071179 Noras or Head HolderSiemens Medical Solutions USA, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK133506 Noras or Head Holder FlexibilityNoras Mri Products GmbH · 2014
- Descendant · cites it directly · 1 of its ownK110411 Atama SystemMonteris Medical, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK091439 Head Fixation Arc and Table BaseSurgivision, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK211658 OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder…Noras Mri Products GmbH · 2022
- Descendant · 2 generations on · 0 of its ownK191701 Arcus Head Fixation FrameMri Interventions, Inc. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K133506Noras or Head Holder FlexibilityNoras Mri Products GmbH · 2014 · cites it directly1descendant
- K110411Atama SystemMonteris Medical, Inc. · 2011 · cites it directly1descendant
- K091439Head Fixation Arc and Table BaseSurgivision, Inc. · 2009 · cites it directly1descendant
- K211658OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet…Noras Mri Products GmbH · 2022 · 2 generations on0descendants
- K191701Arcus Head Fixation FrameMri Interventions, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012495 | OR Table and Headholder/Magnetom Harmony, Symphony, Sonata Systems | Siemens Medical Solutions USA, Inc. | 2001 | 1 |
| 0 (this device) | K071179 | Noras or Head Holder | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +1 | K133506 | Noras or Head Holder Flexibility | Noras Mri Products GmbH | 2014 | — |
| +1 | K110411 | Atama System | Monteris Medical, Inc. | 2011 | — |
| +1 | K091439 | Head Fixation Arc and Table Base | Surgivision, Inc. | 2009 | — |
| +2 | K211658 | OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with… | Noras Mri Products GmbH | 2022 | — |
| +2 | K191701 | Arcus Head Fixation Frame | Mri Interventions, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2019 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K012495 | OR Table and Headholder/Magnetom Harmony, Symphony, Sonata SystemsSummary page 4…ystems is substantially equivalent to the following Neurosurgical OR Head Holder: Device Name Premarket Notification Clearance Date SIEMENS Neurosurgical OR Head Holder K012495 October 31, 2001 Catalog #7548204 7. Summary of Technological Characteristics of the Principal Device as Compared with the predi… | 2001 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has a recall.
- Of its descendants, K133506 (Noras Mri Products GmbH, 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The intended use of the Noras OR Head Holder, in conjunction with a Magnetic Resonance Scanner, is to stabilize patient's head during neurosurgical procedures,
Used in conjunction with Siemens MAGNETOM Systems and the Noras OR Head Coil, it is indicated for use together with a navigation system.
Special Accessories are available for use with the head holder for awake craniotomies, pediatric patients and minimally invasive interventions.
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/K071179 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071179: Noras or Head Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071179
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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