510(k) · Cleared
Cleared1.5T Head Coil (HC150), 3T Head Coil (HC300)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imris, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Feb 2, 2011 as substantially equivalent to K091166 (Imris, Inc., 2009) and 3 other predicates after a 65-day review. Its family tree reaches back 8 generations to 1980. 1 of the 46 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 2, 2011
- Review
- 65 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K801623 (1980). 45 ancestors in all. No later device cites it as a predicate yet. 1 of the 46 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 7 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 6 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 5 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 4 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 3 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 1 generation backK091166 IMRXImris, Inc. · 2009
- This deviceK103506 1.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc. · 2011
Class I recalls in this family
- K083137 Neuro Iii-SVdirect predicate · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −7 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −6 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −5 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −4 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −3 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −2 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −1 | K091166 | IMRX | Imris, Inc. | 2009 | — |
| 0 (this device) | K103506 | 1.5T Head Coil (HC150), 3T Head Coil (HC300) | Imris, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 10 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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? (4)
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 |
|---|---|---|---|
| * | K091166 | IMRXSummary page 2…of the following Medical device systems. Name of the Device 510(k) Number Date of Clearance IMRIS iMRX system K091166 Sep 2, 2009 (SAH Coil-i .5T) __________ IMRIS 3T Intra-operative MRI System (Neur… | 2009 |
| * | K083137 | Neuro Iii-SVSummary page 2…1166 Sep 2, 2009 (SAH Coil-i .5T) __________ IMRIS 3T Intra-operative MRI System (Neuro Ill-SV) K083137 Dec 16, 2008 (SAH Coil-3T) _________ IMRIS 1.5T Intra-operative MRI K… | 2008 |
| * | K061916 | Neuro II-SE, Models or-MB-DR and or-DRSummary page 2…l-SV) K083137 Dec 16, 2008 (SAH Coil-3T) _________ IMRIS 1.5T Intra-operative MRI K(061916 Aug 11, 2006 System (Neuro Il-SE) K071099 May 22, 2007 -(SAHCoil-i .5T)… | 2006 |
| * | K071099 | Neuro II-SE, Models: or-DR-or, or-MBSummary page 2…oil-3T) _________ IMRIS 1.5T Intra-operative MRI K(061916 Aug 11, 2006 System (Neuro Il-SE) K071099 May 22, 2007 -(SAHCoil-i .5T) ___________ 5. SAFETY & EF… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K083137Neuro Iii-SVImris, Inc. · 2008 · Direct predicate · ◆ in the 2008 ancestors bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 31 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 10 of the 45 ancestors have a recall of any class; 1 has a Class I recall.
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?
IMRIS Flex coils HC15O (1.5T Head coil) and HC300 (3T Head coil) are used in conjunction with respective MR Systems IMRIS 1.5T MAGNETOM and IMRIS 3T MAGNETOM as an imaging device for clinical procedures.
IMRIS Flex coils produce images of the human head and upper C-spine internal structures.
When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis and therapy options.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103506: 1.5T Head Coil (HC150), 3T Head Coil (HC300).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103506
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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