510(k) · Cleared
ClearedEmbrace Neonatal MRI System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aspect Imaging, Ltd. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Mar 13, 2026 as substantially equivalent to K170978 (Aspect Imaging, Ltd., 2017) after a 73-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Mar 13, 2026
- Review
- 73 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K001773 (2000). 1 later device descends from it, 1 citing it directly.
- 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 deviceK254277 Embrace Neonatal MRI SystemAspect Imaging, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK261758 Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd. · 2026 · cites it directly0descendants
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) | K254277 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | 2026 | — |
| +1 | K261758 | Embrace Vision Neonatal MRI System | Aspect Imaging, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K170978 | Embrace Neonatal MRI SystemSummary page 5…2026 Classifications: 21 CFR 892.1000 Class: II Product Codes: LNH, MOS Primary Predicate: Embrace Neonatal MRI System (Aspect Imaging, K170978) Page 1 of 8 Indications For Use: The Embrace Neonatal MRI System is ind… | 2017 |
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 |
|---|---|---|---|
| K261758 | Embrace Vision Neonatal MRI System | 2026 | 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 26 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K261758 (Aspect Imaging, Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 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 Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that display the internal structure of neonatal head with circumference of up to 38 cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254277: Embrace Neonatal 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/K254277
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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