510(k) · Cleared
ClearedAtama System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Monteris Medical, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Apr 8, 2011 as substantially equivalent to K060758 (Siemens Medical Solutions USA, Inc., 2006) and 2 other predicates after a 53-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Apr 8, 2011
- Review
- 53 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K013159 (2001). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK013159 HRH-63-8 Head Array CoilMri Devices Corp. · 2001
- 1 generation backK060758 OR Head Coil 1.5 TSiemens Medical Solutions USA, Inc. · 2006
- This deviceK110411 Atama SystemMonteris Medical, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK132444 Atama SystemMonteris Medical, · 2014
Most influential descendants
Showing 1 of 1 · See all- K132444Atama SystemMonteris Medical, · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013159 | HRH-63-8 Head Array Coil | Mri Devices Corp. | 2001 | — |
| −1 | K060758 | OR Head Coil 1.5 T | Siemens Medical Solutions USA, Inc. | 2006 | — |
| 0 (this device) | K110411 | Atama System | Monteris Medical, Inc. | 2011 | — |
| +1 | K132444 | Atama System | Monteris Medical, | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (3)
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 |
|---|---|---|---|
| * | K060758 | OR Head Coil 1.5 TSummary page 1…Noras OR Head Coil 1.5 T Manufacturer: Siemens Medical Solutions USA, Inc. (Noras) K# K060758 Common Name: Noras OR Head Coil 1.5 T Device Classification Name & Citation: Magnetic resonance d… | 2006 |
| * | K071179 | Noras or Head HolderSummary page 1…Noras OR Head Holder Manufacturer: Siemens Medical Solutions USA, Inc. (Noras) K# K071179 Common Name: OR Head Holder Device Classification Name & Citation: Neurosurgical head holder (sku… | 2007 |
| * | K071099 | Neuro II-SE, Models: or-DR-or, or-MBSummary page 2…Intra-operative Imaging System) Manufacturer: IMRIS K# Major Component of K071099 Common Name: Head Coil Kit Device Classification Name & Citation: Magnetic resonance diagnost… | 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 |
|---|---|---|---|
| K132444 | Atama System | 2014 | 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 10 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K132444 (Monteris Medical,, 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K060758.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 AtamA T M System (comprised of two major subsystems: a MR head coil apparatus and a patient stabilization apparatus), in conjunction with a magnetic resonance (MR) imaging system, is the collection of MR data and images of the human brain before, during, and at the end of brain surgery, in a standard operating room, diagnostic MR rooms, or in a MR intra-oiperative room, while stabilizing the patient's head during neurosurgical…
Read the full statement (133 words)
The intended use of the AtamA T M System (comprised of two major subsystems: a MR head coil apparatus and a patient stabilization apparatus), in conjunction with a magnetic resonance (MR) imaging system, is the collection of MR data and images of the human brain before, during, and at the end of brain surgery, in a standard operating room, diagnostic MR rooms, or in a MR intra-oiperative room, while stabilizing the patient's head during neurosurgical procedures and imaging.
The patient head-stabilizing apparatus can also be used for other neurosurgical procedures requiring the patient's head to be stabilized or fixed.
The head coil can also be used as a standard diagnostic head coil for diagnostic MR imaging.
When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110411 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110411: Atama System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110411
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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