510(k) · Cleared
ClearedAscent3T Neonatal Magnetic Resonance Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eyas Medical Imaging, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jan 26, 2026 as substantially equivalent to K170978 (Aspect Imaging, Ltd., 2017) after an 89-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Jan 26, 2026
- Review
- 89 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K001773 (2000). No later device cites it as a predicate yet.
- Root · 5 generations backK001773 OrthoneOni, Inc. · 2000 · Recalled
- 4 generations backK120701 M2 Wrist Mri SystemAspect Imaging, Ltd. · 2013
- 3 generations backK130692 M2 Wrist 2 Mri SystemAspect Imaging, Ltd. · 2014
- 2 generations backK160185 Wrist 3Aspect Imaging, Ltd. · 2016
- 1 generation backK170978 Embrace Neonatal MRI SystemAspect Imaging, Ltd. · 2017
- This deviceK253499 Ascent3T Neonatal Magnetic Resonance Imaging SystemEyas Medical Imaging, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001773 | Orthone | Oni, Inc. | 2000 | 1 |
| −4 | K120701 | M2 Wrist Mri System | Aspect Imaging, Ltd. | 2013 | — |
| −3 | K130692 | M2 Wrist 2 Mri System | Aspect Imaging, Ltd. | 2014 | — |
| −2 | K160185 | Wrist 3 | Aspect Imaging, Ltd. | 2016 | — |
| −1 | K170978 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | 2017 | — |
| 0 (this device) | K253499 | Ascent3T Neonatal Magnetic Resonance Imaging System | Eyas Medical Imaging, Inc. | 2026 | — |
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 |
|---|---|---|---|
| * | K170978 | Embrace Neonatal MRI SystemSummary page 6…Neonatal MRI System Device: Manufacturer: Aspect Imaging Ltd. 510(k) Number: K170978 Product Code: LNH Subsequent Product Code: MOS… | 2017 |
| † | K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems | 2020 |
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 26 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 3 other devices also cite its predicate K170978.
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. 2026, 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 Ascent3T Neonatal Magnetic Resonance Imaging System (Ascent3T) is a whole-body magnetic resonance scanner designed for neonates and infants. The system can produce cross-sectional images of the internal structure of the head, body or extremities in any orientation.
Images produced by the Ascent3T show the spatial distribution of protons exhibiting magnetic resonance. Images produced by the Ascent3T, when interpreted by a trained physician, may provide information useful in diagnosis.
The Ascent3T Neonatal Magnetic Resonance Imaging System is suitable for neonates and infants weighing up to 9kg (19.8 lbs).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253499 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253499: Ascent3T Neonatal Magnetic Resonance Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253499
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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