510(k) · Cleared
ClearedEmbrace Vision 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 Sep 16, 2026 as substantially equivalent to K254277 (Aspect Imaging, Ltd., 2026) after a 111-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Sep 16, 2026
- Review
- 111 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001773 (2000). No later device cites it as a predicate yet.
- Root · 6 generations backK001773 OrthoneOni, Inc. · 2000 · Recalled
- 5 generations backK120701 M2 Wrist Mri SystemAspect Imaging, Ltd. · 2013
- 4 generations backK130692 M2 Wrist 2 Mri SystemAspect Imaging, Ltd. · 2014
- 3 generations backK160185 Wrist 3Aspect Imaging, Ltd. · 2016
- 2 generations backK170978 Embrace Neonatal MRI SystemAspect Imaging, Ltd. · 2017
- 1 generation backK254277 Embrace Neonatal MRI SystemAspect Imaging, Ltd. · 2026
- This deviceK261758 Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001773 | Orthone | Oni, Inc. | 2000 | 1 |
| −5 | K120701 | M2 Wrist Mri System | Aspect Imaging, Ltd. | 2013 | — |
| −4 | K130692 | M2 Wrist 2 Mri System | Aspect Imaging, Ltd. | 2014 | — |
| −3 | K160185 | Wrist 3 | Aspect Imaging, Ltd. | 2016 | — |
| −2 | K170978 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | 2017 | — |
| −1 | K254277 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | 2026 | — |
| 0 (this device) | K261758 | Embrace Vision Neonatal MRI System | Aspect Imaging, Ltd. | 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 |
|---|---|---|---|
| * | K254277 | Embrace Neonatal MRI SystemSummary page 5…sonance Diagnostic Device (21 CFR 892.1000) Class: II Product Codes: LNH, MOS Primary Predicate: Embrace Neonatal MRI System (Aspect Imaging, K254277) Page 1 of 4 510(k)… | 2026 |
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 2 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
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 Vision 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/K261758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261758: Embrace Vision 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/K261758
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026