510(k) · Cleared
ClearedSwiftMR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airs Medical, Inc. · LLZ System, Image Processing, Radiological
Cleared on May 25, 2022 as substantially equivalent to K210999 (Airs Medical, Inc., 2021) after a 100-day review. Its family tree reaches back 6 generations to 1992. 4 later devices descend from it.
- Decided
- May 25, 2022
- Review
- 100 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K922470 (1992). 4 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 5 generations backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- 4 generations backK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- 3 generations backK172768 ZOOMZetta Medical Technologies, LLC · 2018
- 2 generations backK191688 SubtleMRSubtle Medical, Inc. · 2019
- 1 generation backK210999 SwiftMRAirs Medical, Inc. · 2021
- This deviceK220416 SwiftMRAirs Medical, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK230854 SwiftMRAirs Medical, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK253775 SwiftMRAirs Medical, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK261349 SwiftMRAirs Medical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK243250 SubtleHD (1.x)Subtle Medical, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| −5 | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| −4 | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| −3 | K172768 | ZOOM | Zetta Medical Technologies, LLC | 2018 | — |
| −2 | K191688 | SubtleMR | Subtle Medical, Inc. | 2019 | — |
| −1 | K210999 | SwiftMR | Airs Medical, Inc. | 2021 | — |
| 0 (this device) | K220416 | SwiftMR | Airs Medical, Inc. | 2022 | — |
| +1 | K230854 | SwiftMR | Airs Medical, Inc. | 2023 | — |
| +2 | K253775 | SwiftMR | Airs Medical, Inc. | 2026 | — |
| +3 | K261349 | SwiftMR | Airs Medical, Inc. | 2026 | — |
| +2 | K243250 | SubtleHD (1.x) | Subtle Medical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K210999 | SwiftMRSummary page 4…mage processing, radiological (21 CFR 892.2050) Regulatory Class: II Product Code: LLZ III. PREDICATE DEVICE Primary Predicate Device: SwiftMR – K210999 by AIRS Medical, Inc., Class II, CFR 892.2050, classification with product code LLZ. IV. DEVICE DESCRIPTION Swif… | 2021 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230854 | SwiftMR | 2023 | 3 |
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 30 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K230854 (Airs Medical, Inc., 2023) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K210999.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
SwiftMR is a stand-alone software solution intended to be used for acceptance, enhancement and transfer of brain, spine, knee, ankle, shoulder and hip MR images in DICOM format. It can be used for noise reduction and increasing image sharpness for non-contrast enhanced MR images.
SwiftMR is not intended for use on mobile devices.
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/K220416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220416: SwiftMR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220416
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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