510(k) · Cleared
ClearedSwoop® Portable MR Imaging® System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hyperfine, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Dec 12, 2025 as substantially equivalent to K250236 (Hyperfine, Inc., 2025) and 1 other predicate after a 49-day review. Its family tree reaches back 13 generations to 2000. 1 later device descends from it.
- Decided
- Dec 12, 2025
- Review
- 49 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K001773 (2000). 16 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK001773 OrthoneOni, Inc. · 2000 · Recalled
- 9 generations between
- 3 generations backK232760 Swoop® Portable MR Imaging System®Hyperfine, Inc. · 2023
- 2 generations backK240944 Swoop® Portable MR Imaging® SystemHyperfine, Inc. · 2024
- 1 generation backK251276 Swoop® Portable MR Imaging® SystemHyperfine, Inc. · 2025
- This deviceK253489 Swoop® Portable MR Imaging® SystemHyperfine, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK262622 Swoop® Portable MR Imaging® SystemHyperfine, Inc. · 2026
Show all 13 generations
- Root · 13 generations backK001773 OrthoneOni, Inc. · 2000 · Recalled
- 12 generations backK120701 M2 Wrist Mri SystemAspect Imaging, Ltd. · 2013
- 11 generations backK130692 M2 Wrist 2 Mri SystemAspect Imaging, Ltd. · 2014
- 10 generations backK160185 Wrist 3Aspect Imaging, Ltd. · 2016
- 9 generations backK170978 Embrace Neonatal MRI SystemAspect Imaging, Ltd. · 2017
- 8 generations backK192002 Lucy Point-of-Care Magnetic Resonance Imaging DeviceHyperfine Research, Inc. · 2020
- 7 generations backK201722 Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner…Hyperfine Research, Inc. · 2020
- 6 generations backK221923 Swoop Portable MR Imaging SystemHyperfine, Inc. · 2022
- 5 generations backK223247 Swoop Portable MR Imaging SystemHyperfine, Inc. · 2022
- 4 generations backK230208 Swoop® Portable MR Imaging System™Hyperfine, Inc. · 2023
- 3 generations backK232760 Swoop® Portable MR Imaging System®Hyperfine, Inc. · 2023
- 2 generations backK240944 Swoop® Portable MR Imaging® SystemHyperfine, Inc. · 2024
- 1 generation backK251276 Swoop® Portable MR Imaging® SystemHyperfine, Inc. · 2025
- This deviceK253489 Swoop® Portable MR Imaging® SystemHyperfine, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K001773 | Orthone | Oni, Inc. | 2000 | 1 |
| −12 | K120701 | M2 Wrist Mri System | Aspect Imaging, Ltd. | 2013 | — |
| −11 | K130692 | M2 Wrist 2 Mri System | Aspect Imaging, Ltd. | 2014 | — |
| −10 | K160185 | Wrist 3 | Aspect Imaging, Ltd. | 2016 | — |
| −9 | K170978 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | 2017 | — |
| −8 | K192002 | Lucy Point-of-Care Magnetic Resonance Imaging Device | Hyperfine Research, Inc. | 2020 | — |
| −7 | K201722 | Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Hyperfine Research, Inc. | 2020 | — |
| −6 | K221923 | Swoop Portable MR Imaging System | Hyperfine, Inc. | 2022 | — |
| −5 | K223247 | Swoop Portable MR Imaging System | Hyperfine, Inc. | 2022 | — |
| −4 | K230208 | Swoop® Portable MR Imaging System™ | Hyperfine, Inc. | 2023 | — |
| −3 | K232760 | Swoop® Portable MR Imaging System® | Hyperfine, Inc. | 2023 | — |
| −2 | K240944 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2024 | — |
| −1 | K251276 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2025 | — |
| 0 (this device) | K253489 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2025 | — |
| +1 | K262622 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K250236 | Swoop® Portable MR Imaging® System (V2)Summary page 5…tory Class: Class II PREDICATE DEVICE INFORMATION The subject Swoop Portable MR Imaging System is substantially equivalent to the primary predicate Swoop System (K250236), and the secondary predicate Swoop System (K251276). DEVICE DESCRIPTION The Swoop System is portable, ultra-low field MRI devi… | 2025 |
| * | K251276 | Swoop® Portable MR Imaging® SystemSummary page 5…TION The subject Swoop Portable MR Imaging System is substantially equivalent to the primary predicate Swoop System (K250236), and the secondary predicate Swoop System (K251276). DEVICE DESCRIPTION The Swoop System is portable, ultra-low field MRI device that enables visualization of the internal struct… | 2025 |
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 |
|---|---|---|---|
| K262622 | Swoop® Portable MR Imaging® 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 25 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K262622 (Hyperfine, Inc., 2026) 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. 2025, 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 Swoop Portable MR Imaging System is a portable, ultra-low field magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
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/K253489 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253489: Swoop® Portable MR 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/K253489
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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