510(k) · Cleared
ClearedHyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hyperfine Research, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Aug 11, 2020 as substantially equivalent to K192002 (Hyperfine Research, Inc., 2020) after a 49-day review. Its family tree reaches back 6 generations to 2000. 10 later devices descend from it.
- Decided
- Aug 11, 2020
- Review
- 49 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001773 (2000). 10 later devices descend from it, 2 citing it directly.
- 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 backK192002 Lucy Point-of-Care Magnetic Resonance Imaging DeviceHyperfine Research, Inc. · 2020
- This deviceK201722 Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner…Hyperfine Research, Inc. · 2020
- Descendant · cites it directly · 8 of its ownK221923 Swoop Portable MR Imaging SystemHyperfine, Inc. · 2022
- Descendant · 2 generations on · 7 of its ownK223247 Swoop Portable MR Imaging SystemHyperfine, Inc. · 2022
- Descendant · 3 generations on · 6 of its ownK230208 Swoop® Portable MR Imaging System™Hyperfine, Inc. · 2023
- Descendant · 4 generations on · 5 of its ownK232760 Swoop® Portable MR Imaging System®Hyperfine, Inc. · 2023
- Descendant · 5 generations on · 4 of its ownK240944 Swoop® Portable MR Imaging® SystemHyperfine, Inc. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K221923Swoop Portable MR Imaging SystemHyperfine, Inc. · 2022 · cites it directly8descendants
- K223247Swoop Portable MR Imaging SystemHyperfine, Inc. · 2022 · 2 generations on7descendants
- K230208Swoop® Portable MR Imaging System™Hyperfine, Inc. · 2023 · 3 generations on6descendants
- K232760Swoop® Portable MR Imaging System®Hyperfine, Inc. · 2023 · 4 generations on5descendants
- K240944Swoop® Portable MR Imaging® SystemHyperfine, Inc. · 2024 · 5 generations on4descendants
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 | K192002 | Lucy Point-of-Care Magnetic Resonance Imaging Device | Hyperfine Research, Inc. | 2020 | — |
| 0 (this device) | K201722 | Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Hyperfine Research, Inc. | 2020 | — |
| +1 | K221923 | Swoop Portable MR Imaging System | Hyperfine, Inc. | 2022 | — |
| +2 | K223247 | Swoop Portable MR Imaging System | Hyperfine, Inc. | 2022 | — |
| +3 | K230208 | Swoop® Portable MR Imaging System™ | Hyperfine, Inc. | 2023 | — |
| +4 | K232760 | Swoop® Portable MR Imaging System® | Hyperfine, Inc. | 2023 | — |
| +5 | K240944 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 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? (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 |
|---|---|---|---|
| * | K192002 | Lucy Point-of-Care Magnetic Resonance Imaging DeviceSummary page 5…yste_m, Nuclear Magnetic Resonance 892.1000 90-LNH Imaging Coil, Magnetic Resonance, Specialty 892.1000 90-MOS Classification Class Il Predicate Device: K192002 — Lucy Point-of-Care Magnetic Resonance Imaging Device, Hyperfine Research, Inc. Device Summary: The Point-Of-Care Magnetic Res… | 2020 |
What descends from it? (10)
2 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 20 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K221923 (Hyperfine, Inc., 2022) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K192002.
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. 2020, 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 Point-of-Care Magnetic Resonance Imaging Device is a bedside magnetic resonance imaging device for producing images that display the internal stmcture 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/K201722 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201722: Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201722
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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