510(k) · Cleared
ClearedInVision™ 3T Recharge Operating Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imris Imaging, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Aug 6, 2025 as substantially equivalent to K212367 (Deerfield Imaging, Inc., 2021) after a 20-day review. Its family tree reaches back 3 generations to 2007. 3 of the 5 devices in its family, counting itself, have a Class I recall.
- Decided
- Aug 6, 2025
- Review
- 20 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K071099 (2007). 4 ancestors in all. No later device cites it as a predicate yet. 3 of the 5 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK071099 Neuro II-SE, Models: or-DR-or, or-MBImris, Inc. · 2007 · Recalled
- 2 generations backK133692 Imri 1.5T and Imri 3T SImris, Inc. · 2014 · Recalled (Class I)
- 1 generation backK212367 IMRIS iMRI 3T VDeerfield Imaging, Inc. · 2021 · Recalled (Class I)
- This deviceK252239 InVision™ 3T Recharge Operating SuiteImris Imaging, Inc. · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K071099 | Neuro II-SE, Models: or-DR-or, or-MB | Imris, Inc. | 2007 | 2 |
| −2 | K133692 | Imri 1.5T and Imri 3T S | Imris, Inc. | 2014 | Class I |
| −1 | K212367 | IMRIS iMRI 3T V | Deerfield Imaging, Inc. | 2021 | Class I |
| 0 (this device) | K252239 | InVision™ 3T Recharge Operating Suite | Imris Imaging, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
3 devices in this family have 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? (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 |
|---|---|---|---|
| * | K212367 | IMRIS iMRI 3T VSummary page 5…: Primary: LNH Secondary: LNI, MOS III. PREDICATE DEVICE Device Name: IMRIS iMRI 3T V 510(k) Number: K212367 Common Name: MRDD (Magnetic Resonance Diagnostic Device) Classification Name: System, Nuclear Magnetic Reso… | 2021 |
| † | K220589 | MAGNETOM Skyra Fit | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K212367IMRIS iMRI 3T VDeerfield Imaging, Inc. · 2021 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
- K133692Imri 1.5T and Imri 3T SImris, Inc. · 2014 · 2 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
- K083137Neuro Iii-SVImris, Inc. · 2008 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- 4 of the 4 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K212367.
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. 2025, 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?
The InVision™ 3T Recharge Operating Suite is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast…
Read the full statement (146 words)
The InVision™ 3T Recharge Operating Suite is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body or extremities.
Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The InVision™ 3T Recharge Operating Suite may also be used for imaging during intraoperative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner.
The InVision™ 3T Recharge Operating Suite 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/K252239 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252239: InVision™ 3T Recharge Operating Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252239
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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