510(k) · Cleared
ClearedSwiftMR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airs Medical, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Jul 24, 2026 as substantially equivalent to K253775 (Airs Medical, Inc., 2026) after a 91-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Jul 24, 2026
- Review
- 91 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K922470 (1992). No later device cites it as a predicate yet.
- Root · 9 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 5 generations between
- 3 generations backK220416 SwiftMRAirs Medical, Inc. · 2022
- 2 generations backK230854 SwiftMRAirs Medical, Inc. · 2023
- 1 generation backK253775 SwiftMRAirs Medical, Inc. · 2026
- This deviceK261349 SwiftMRAirs Medical, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 8 generations backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- 7 generations backK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- 6 generations backK172768 ZOOMZetta Medical Technologies, LLC · 2018
- 5 generations backK191688 SubtleMRSubtle Medical, Inc. · 2019
- 4 generations backK210999 SwiftMRAirs Medical, Inc. · 2021
- 3 generations backK220416 SwiftMRAirs Medical, Inc. · 2022
- 2 generations backK230854 SwiftMRAirs Medical, Inc. · 2023
- 1 generation backK253775 SwiftMRAirs Medical, Inc. · 2026
- This deviceK261349 SwiftMRAirs Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| −8 | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| −7 | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| −6 | K172768 | ZOOM | Zetta Medical Technologies, LLC | 2018 | — |
| −5 | K191688 | SubtleMR | Subtle Medical, Inc. | 2019 | — |
| −4 | K210999 | SwiftMR | Airs Medical, Inc. | 2021 | — |
| −3 | K220416 | SwiftMR | Airs Medical, Inc. | 2022 | — |
| −2 | K230854 | SwiftMR | Airs Medical, Inc. | 2023 | — |
| −1 | K253775 | SwiftMR | Airs Medical, Inc. | 2026 | — |
| 0 (this device) | K261349 | SwiftMR | Airs Medical, Inc. | 2026 | — |
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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 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 |
|---|---|---|---|
| * | K253775 | SwiftMRSummary page 5…ystem, image processing, radiological (21 CFR 892.2050) Regulatory Class: II Product Code: QIH III. PREDICATE DEVICE Predicate Device: SwiftMR – K253775 by AIRS Medical, Inc., Class II, CFR 892.2050, classification with product code QIH. IV. DEVICE DESCRIPTION SwiftM… | 2026 |
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 34 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
SwiftMR is a stand-alone medical imaging software solution intended for the acceptance, enhancement, processing, review, analysis, communication, and transfer of MR images in DICOM format. The software may be used for the enhancement of medical images, such as noise reduction and increased image sharpness, as well as for image processing, such as segmentation to remove background anatomy for Maximum Intensity Projection (MIP) visualization. The device is…
Read the full statement (113 words)
SwiftMR is a stand-alone medical imaging software solution intended for the acceptance, enhancement, processing, review, analysis, communication, and transfer of MR images in DICOM format. The software may be used for the enhancement of medical images, such as noise reduction and increased image sharpness, as well as for image processing, such as segmentation to remove background anatomy for Maximum Intensity Projection (MIP) visualization.
The device is designed for use by healthcare professionals and is intended to assist clinicians, who remain responsible for making all final patient management decisions. The device is not intended for use on mobile devices.
The available field strengths are as follows: 0.25T, 0.31T, 0.4T, 0.55T, 0.6T, 1.5T, and 3.0T.
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/K261349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261349: SwiftMR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261349
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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