510(k) · Cleared
ClearedPromaxo MRI System
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 Mar 3, 2021 as substantially equivalent to K113281 (Shenzhen Anke High-Tech Co., Ltd., 2012) after a 183-day review. Its family tree reaches back 3 generations to 2008. 1 later device descends from it.
- Decided
- Mar 3, 2021
- Review
- 183 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K073457 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK073457 Mstar MPD4500Xinaomdt Technology Co., Ltd. · 2008
- 2 generations backK091580 Pica Whole Body Mri SystemTime Medical Limited · 2009
- 1 generation backK113281 Mri SytemsShenzhen Anke High-Tech Co., Ltd. · 2012
- This deviceK202518 Promaxo MRI SystemPromaxo, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK232361 Promaxo MRI System IIPromaxo, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K232361Promaxo MRI System IIPromaxo, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K073457 | Mstar MPD4500 | Xinaomdt Technology Co., Ltd. | 2008 | — |
| −2 | K091580 | Pica Whole Body Mri System | Time Medical Limited | 2009 | — |
| −1 | K113281 | Mri Sytems | Shenzhen Anke High-Tech Co., Ltd. | 2012 | — |
| 0 (this device) | K202518 | Promaxo MRI System | Promaxo, Inc. | 2021 | — |
| +1 | K232361 | Promaxo MRI System II | Promaxo, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 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 |
|---|---|---|---|
| * | K113281 | Mri SytemsSummary page 4…Product Manufacturer K-number Code ASM-030PIII MRI Systems II LNH Shenzhen Anke K113281 (OPENMARK 111), High-Tech Co. ASM-040P… | 2012 |
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 |
|---|---|---|---|
| K232361 | Promaxo MRI System II | 2023 | 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 13 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K232361 (Promaxo, Inc., 2023) has gone furthest, with 0 descendants of its own.
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. 2021, 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 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 a 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/K202518 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202518: Promaxo MRI System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202518
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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