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 Jul 28, 2022 as substantially equivalent to K201722 (Hyperfine Research, Inc., 2020) and 1 other predicate after a 27-day review. Its family tree reaches back 7 generations to 2000. 8 later devices descend from it.
- Decided
- Jul 28, 2022
- Review
- 27 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K001773 (2000). 9 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK001773 OrthoneOni, Inc. · 2000 · Recalled
- 6 generations backK120701 M2 Wrist Mri SystemAspect Imaging, Ltd. · 2013
- 5 generations backK130692 M2 Wrist 2 Mri SystemAspect Imaging, Ltd. · 2014
- 4 generations backK160185 Wrist 3Aspect Imaging, Ltd. · 2016
- 3 generations backK170978 Embrace Neonatal MRI SystemAspect Imaging, Ltd. · 2017
- 2 generations backK192002 Lucy Point-of-Care Magnetic Resonance Imaging DeviceHyperfine Research, Inc. · 2020
- 1 generation backK201722 Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner…Hyperfine Research, Inc. · 2020
- This deviceK221923 Swoop Portable MR Imaging SystemHyperfine, Inc. · 2022
- Descendant · cites it directly · 7 of its ownK223247 Swoop Portable MR Imaging SystemHyperfine, Inc. · 2022
- Descendant · 2 generations on · 6 of its ownK230208 Swoop® Portable MR Imaging System™Hyperfine, Inc. · 2023
- Descendant · 3 generations on · 5 of its ownK232760 Swoop® Portable MR Imaging System®Hyperfine, Inc. · 2023
- Descendant · 4 generations on · 4 of its ownK240944 Swoop® Portable MR Imaging® SystemHyperfine, Inc. · 2024
- Descendant · 5 generations on · 2 of its ownK250236 Swoop® Portable MR Imaging® System (V2)Hyperfine, Inc. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K223247Swoop Portable MR Imaging SystemHyperfine, Inc. · 2022 · cites it directly7descendants
- K230208Swoop® Portable MR Imaging System™Hyperfine, Inc. · 2023 · 2 generations on6descendants
- K232760Swoop® Portable MR Imaging System®Hyperfine, Inc. · 2023 · 3 generations on5descendants
- K240944Swoop® Portable MR Imaging® SystemHyperfine, Inc. · 2024 · 4 generations on4descendants
- K250236Swoop® Portable MR Imaging® System (V2)Hyperfine, Inc. · 2025 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001773 | Orthone | Oni, Inc. | 2000 | 1 |
| −6 | K120701 | M2 Wrist Mri System | Aspect Imaging, Ltd. | 2013 | — |
| −5 | K130692 | M2 Wrist 2 Mri System | Aspect Imaging, Ltd. | 2014 | — |
| −4 | K160185 | Wrist 3 | Aspect Imaging, Ltd. | 2016 | — |
| −3 | K170978 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | 2017 | — |
| −2 | K192002 | Lucy Point-of-Care Magnetic Resonance Imaging Device | Hyperfine Research, Inc. | 2020 | — |
| −1 | K201722 | Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Hyperfine Research, Inc. | 2020 | — |
| 0 (this device) | K221923 | Swoop Portable MR Imaging System | Hyperfine, Inc. | 2022 | — |
| +1 | K223247 | Swoop Portable MR Imaging System | Hyperfine, Inc. | 2022 | — |
| +2 | K230208 | Swoop® Portable MR Imaging System™ | Hyperfine, Inc. | 2023 | — |
| +3 | K232760 | Swoop® Portable MR Imaging System® | Hyperfine, Inc. | 2023 | — |
| +4 | K240944 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2024 | — |
| +5 | K250236 | Swoop® Portable MR Imaging® System (V2) | Hyperfine, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 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 |
|---|---|---|---|
| * | K201722 | Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemSummary page 4…Specialty Product Code: LNH; MOS Regulatory Class: Class II PREDICATE DEVICE INFORMATION The subject Swoop® Portable MR Imaging System™ (K201722/K221393). DEVICE DESCRIPTION The Swoop® system is a portable MRI device that allows for patient bedside imaging. The system ena… | 2020 |
| * | K221393 | Swoop Portable MR Imaging SystemSummary page 4…Specialty Product Code: LNH; MOS Regulatory Class: Class II PREDICATE DEVICE INFORMATION The subject Swoop® Portable MR Imaging System™ (K201722/K221393). DEVICE DESCRIPTION The Swoop® system is a portable MRI device that allows for patient bedside imaging. The system enables vis… | 2022 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223247 | Swoop Portable MR Imaging System | 2022 | 7 |
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 22 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K223247 (Hyperfine, Inc., 2022) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K201722.
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. 2022, 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?
Hyperfine Swoop® Portable MR Imaging System(TM) is a bedside 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/K221923 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221923: 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/K221923
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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