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 Aug 19, 2026 as substantially equivalent to K253489 (Hyperfine, Inc., 2025) after a 22-day review. Its family tree reaches back 14 generations to 2000.
- Decided
- Aug 19, 2026
- Review
- 22 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K001773 (2000). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK001773 OrthoneOni, Inc. · 2000 · Recalled
- 10 generations between
- 3 generations backK240944 Swoop® Portable MR Imaging® SystemHyperfine, Inc. · 2024
- 2 generations backK251276 Swoop® Portable MR Imaging® SystemHyperfine, Inc. · 2025
- 1 generation backK253489 Swoop® Portable MR Imaging® SystemHyperfine, Inc. · 2025
- This deviceK262622 Swoop® Portable MR Imaging® SystemHyperfine, Inc. · 2026
Show all 14 generations
- Root · 14 generations backK001773 OrthoneOni, Inc. · 2000 · Recalled
- 13 generations backK120701 M2 Wrist Mri SystemAspect Imaging, Ltd. · 2013
- 12 generations backK130692 M2 Wrist 2 Mri SystemAspect Imaging, Ltd. · 2014
- 11 generations backK160185 Wrist 3Aspect Imaging, Ltd. · 2016
- 10 generations backK170978 Embrace Neonatal MRI SystemAspect Imaging, Ltd. · 2017
- 9 generations backK192002 Lucy Point-of-Care Magnetic Resonance Imaging DeviceHyperfine Research, Inc. · 2020
- 8 generations backK201722 Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner…Hyperfine Research, Inc. · 2020
- 7 generations backK221923 Swoop Portable MR Imaging SystemHyperfine, Inc. · 2022
- 6 generations backK223247 Swoop Portable MR Imaging SystemHyperfine, Inc. · 2022
- 5 generations backK230208 Swoop® Portable MR Imaging System™Hyperfine, Inc. · 2023
- 4 generations backK232760 Swoop® Portable MR Imaging System®Hyperfine, Inc. · 2023
- 3 generations backK240944 Swoop® Portable MR Imaging® SystemHyperfine, Inc. · 2024
- 2 generations backK251276 Swoop® Portable MR Imaging® SystemHyperfine, Inc. · 2025
- 1 generation backK253489 Swoop® Portable MR Imaging® SystemHyperfine, Inc. · 2025
- This deviceK262622 Swoop® Portable MR Imaging® SystemHyperfine, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K001773 | Orthone | Oni, Inc. | 2000 | 1 |
| −13 | K120701 | M2 Wrist Mri System | Aspect Imaging, Ltd. | 2013 | — |
| −12 | K130692 | M2 Wrist 2 Mri System | Aspect Imaging, Ltd. | 2014 | — |
| −11 | K160185 | Wrist 3 | Aspect Imaging, Ltd. | 2016 | — |
| −10 | K170978 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | 2017 | — |
| −9 | K192002 | Lucy Point-of-Care Magnetic Resonance Imaging Device | Hyperfine Research, Inc. | 2020 | — |
| −8 | K201722 | Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Hyperfine Research, Inc. | 2020 | — |
| −7 | K221923 | Swoop Portable MR Imaging System | Hyperfine, Inc. | 2022 | — |
| −6 | K223247 | Swoop Portable MR Imaging System | Hyperfine, Inc. | 2022 | — |
| −5 | K230208 | Swoop® Portable MR Imaging System™ | Hyperfine, Inc. | 2023 | — |
| −4 | K232760 | Swoop® Portable MR Imaging System® | Hyperfine, Inc. | 2023 | — |
| −3 | K240944 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2024 | — |
| −2 | K251276 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2025 | — |
| −1 | K253489 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2025 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K253489 | Swoop® Portable MR Imaging® SystemSummary page 5…S Regulatory Class: Class II PREDICATE DEVICE INFORMATION The subject Swoop Portable MR Imaging System is substantially equivalent to the predicate Swoop System (K253489). DEVICE DESCRIPTION The Swoop Portable MR Imaging System is a portable, ultra-low field MRI device that enables visualization… | 2025 |
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 4 companies; a new generation was cleared every 10 months on median.
- 1 of the 17 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 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 as stated in the FDA summary.
https://510kreport.com/device/K262622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262622: Swoop® Portable MR Imaging® System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262622
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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