510(k) · Cleared
ClearedPromaxo MRI System II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promaxo, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Sep 5, 2023 as substantially equivalent to K202518 (Promaxo, Inc., 2021) after a 29-day review. Its family tree reaches back 4 generations to 2008.
- Decided
- Sep 5, 2023
- Review
- 29 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K073457 (2008). No later device cites it as a predicate yet.
- Root · 4 generations backK073457 Mstar MPD4500Xinaomdt Technology Co., Ltd. · 2008
- 3 generations backK091580 Pica Whole Body Mri SystemTime Medical Limited · 2009
- 2 generations backK113281 Mri SytemsShenzhen Anke High-Tech Co., Ltd. · 2012
- 1 generation backK202518 Promaxo MRI SystemPromaxo, Inc. · 2021
- This deviceK232361 Promaxo MRI System IIPromaxo, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K073457 | Mstar MPD4500 | Xinaomdt Technology Co., Ltd. | 2008 | — |
| −3 | K091580 | Pica Whole Body Mri System | Time Medical Limited | 2009 | — |
| −2 | K113281 | Mri Sytems | Shenzhen Anke High-Tech Co., Ltd. | 2012 | — |
| −1 | K202518 | Promaxo MRI System | Promaxo, Inc. | 2021 | — |
| 0 (this device) | K232361 | Promaxo MRI System II | Promaxo, Inc. | 2023 | — |
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 LNH? 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 |
|---|---|---|---|
| * | K202518 | Promaxo MRI SystemSummary page 4…2.1000 Product Code LNH / MOS | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K202518 Promaxo MRI System LNH/MOS Device Description Summary 21 CFR 807.92(a)(4) The MRI System that is subject of this 510(k) is ident… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 4 ancestors has a recall.
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. 2023, 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 Promaxo Magnetic Resonance Imaging (MRI) System Il is an office-based MRI system for
producing images that display the prostate and adjoining tissues. When used by a trained urologist
or interventional/urologic radiologist, the system is intended to be used for targeting prostatic lesions
under MR guidance in alignment with the current standard of care. Promaxo MR images are not
intended to be used for diagnostic purposes, and either a 1.5T or 3T MR image acquired without an
endorectal coil is a required input for guidance using the Promaxo MRI System.
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/K232361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232361: Promaxo MRI System II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232361
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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