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 Jul 19, 2017 as substantially equivalent to K160185 (Aspect Imaging, Ltd., 2016) after a 107-day review. Its family tree reaches back 4 generations to 2000. 17 later devices descend from it.
- Decided
- Jul 19, 2017
- Review
- 107 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001773 (2000). 17 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK001773 OrthoneOni, Inc. · 2000 · Recalled
- 3 generations backK120701 M2 Wrist Mri SystemAspect Imaging, Ltd. · 2013
- 2 generations backK130692 M2 Wrist 2 Mri SystemAspect Imaging, Ltd. · 2014
- 1 generation backK160185 Wrist 3Aspect Imaging, Ltd. · 2016
- This deviceK170978 Embrace Neonatal MRI SystemAspect Imaging, Ltd. · 2017
- Descendant · cites it directly · 13 of its ownK192002 Lucy Point-of-Care Magnetic Resonance Imaging DeviceHyperfine Research, Inc. · 2020
- Descendant · 2 generations on · 10 of its ownK201722 Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner…Hyperfine Research, Inc. · 2020
- Descendant · 3 generations on · 8 of its ownK221923 Swoop Portable MR Imaging SystemHyperfine, Inc. · 2022
- Descendant · 4 generations on · 7 of its ownK223247 Swoop Portable MR Imaging SystemHyperfine, Inc. · 2022
- Descendant · 5 generations on · 6 of its ownK230208 Swoop® Portable MR Imaging System™Hyperfine, Inc. · 2023
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K192002Lucy Point-of-Care Magnetic Resonance Imaging DeviceHyperfine Research, Inc. · 2020 · cites it directly13descendants
- K201722Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemHyperfine Research, Inc. · 2020 · 2 generations on10descendants
- K221923Swoop Portable MR Imaging SystemHyperfine, Inc. · 2022 · 3 generations on8descendants
- K223247Swoop Portable MR Imaging SystemHyperfine, Inc. · 2022 · 4 generations on7descendants
- K230208Swoop® Portable MR Imaging System™Hyperfine, Inc. · 2023 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001773 | Orthone | Oni, Inc. | 2000 | 1 |
| −3 | K120701 | M2 Wrist Mri System | Aspect Imaging, Ltd. | 2013 | — |
| −2 | K130692 | M2 Wrist 2 Mri System | Aspect Imaging, Ltd. | 2014 | — |
| −1 | K160185 | Wrist 3 | Aspect Imaging, Ltd. | 2016 | — |
| 0 (this device) | K170978 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | 2017 | — |
| +1 | K192002 | Lucy Point-of-Care Magnetic Resonance Imaging Device | Hyperfine Research, Inc. | 2020 | — |
| +2 | K201722 | Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Hyperfine Research, Inc. | 2020 | — |
| +3 | K221923 | Swoop Portable MR Imaging System | Hyperfine, Inc. | 2022 | — |
| +4 | K223247 | Swoop Portable MR Imaging System | Hyperfine, Inc. | 2022 | — |
| +5 | K230208 | Swoop® Portable MR Imaging System™ | Hyperfine, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K160185 | Wrist 3Summary page 4…lassification Name: Magnetic Resonance Diagnostic Device (21 CFR 892.1000) Product Code: LNH, MOS Predicate Device(s): K160185 Wrist 3 MRI System Reference Device(s) K161918 SREE MRI Transport Incubator* *referenced for th… | 2016 |
| † | K161918 | SREE MRI Transport Incubator | 2017 |
What descends from it? (17)
See all 174 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K192002 (Hyperfine Research, Inc., 2020) has gone furthest, with 13 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. 2017, 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 displays 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/K170978 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170978: 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/K170978
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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