510(k) · Cleared
ClearedIMRX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imris, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Sep 2, 2009 as substantially equivalent to K073290 (Siemens Medical Solutions USA, Inc., 2008) and 3 other predicates after a 133-day review. Its family tree reaches back 7 generations to 1980. 1 of the 46 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Sep 2, 2009
- Review
- 133 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K801623 (1980). 44 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 46 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 6 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 5 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 4 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 3 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 2 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 1 generation backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- This deviceK091166 IMRXImris, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK103506 1.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc. · 2011
Class I recalls in this family
- K083137 Neuro Iii-SVdirect predicate · 2008
Most influential descendants
Showing 1 of 1 · See all- K1035061.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −6 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −5 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −4 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −3 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −2 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −1 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| 0 (this device) | K091166 | IMRX | Imris, Inc. | 2009 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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.
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 LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 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 |
|---|---|---|---|
| * | K073290 | Artis Zee and ZeegoSummary page 2…dical devices. Predicate Device name 510(k) Number FDA Clearance date Siemens Artis zee / zeego K073290 Feb 11, 2008 IMRIS Neuro III-SV Intra-operative MRI System K083137 Dec 16, 2008 IMRIS Neur… | 2008 |
| * | K083137 | Neuro Iii-SVSummary page 2…FDA Clearance date Siemens Artis zee / zeego K073290 Feb 11, 2008 IMRIS Neuro III-SV Intra-operative MRI System K083137 Dec 16, 2008 IMRIS Neuro Il-SE Intra-operative MRI System K061916 Aug 11,2006… | 2008 |
| * | K061916 | Neuro II-SE, Models or-MB-DR and or-DRSummary page 2…Feb 11, 2008 IMRIS Neuro III-SV Intra-operative MRI System K083137 Dec 16, 2008 IMRIS Neuro Il-SE Intra-operative MRI System K061916 Aug 11,2006 K071099 May 22, 2007 6. SAFETY& EFF… | 2006 |
| * | K071099 | Neuro II-SE, Models: or-DR-or, or-MBSummary page 2…Dec 16, 2008 IMRIS Neuro Il-SE Intra-operative MRI System K061916 Aug 11,2006 K071099 May 22, 2007 6. SAFETY& EFFECTIVENESS The iMRX has been designed to provide MRI imaging in an intra-operative settin… | 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 |
|---|---|---|---|
| K103506 | 1.5T Head Coil (HC150), 3T Head Coil (HC300) | 2011 | 0 |
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 29 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 10 of the 44 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K103506 (Imris, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K073290.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, 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 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
iMRX is an integrated imaging system combining X-ray Angiography and Magnetic Resonance for interventional, diagnostic, and intra-operative imaging. The iMRX system uses the Artis zee family of dedicated angiography systems for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the iMRX system include cardiac angiography, neuro-angiography…
Read the full statement (216 words)
iMRX is an integrated imaging system combining X-ray Angiography and Magnetic Resonance for interventional, diagnostic, and intra-operative imaging.
The iMRX system uses the Artis zee family of dedicated angiography systems for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the iMRX system include cardiac angiography, neuro-angiography, general angiography, rotational angiography, operating room angiography and whole body radiographic/fluoroscopic procedures. The iMRX system can also support the acquisition of position triggered imaging for spatial data synthesis.
The iMRX system uses the IMRIS family of Intra-operative MRI systems indicated for use as a magnetic resonance diagnostic device (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and / or spectra, and that display the internal structure and / or function of the head and whole body. Depending on the region of interest, contrast agents may be used. These images and / or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The iMRX system may also be used for imaging during intra-operative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner.
The iMRX system may also be used for imaging in a multi-room suite.
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/K091166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091166: IMRX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091166
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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