510(k) · Cleared
ClearedSubtleHD (1.x)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Subtle Medical, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Feb 12, 2025 as substantially equivalent to K230854 (Airs Medical, Inc., 2023) and 1 other predicate after a 120-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Feb 12, 2025
- Review
- 120 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K922470 (1992). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 7 generations backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- 6 generations backK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- 5 generations backK172768 ZOOMZetta Medical Technologies, LLC · 2018
- 4 generations backK191688 SubtleMRSubtle Medical, Inc. · 2019
- 3 generations backK210999 SwiftMRAirs Medical, Inc. · 2021
- 2 generations backK220416 SwiftMRAirs Medical, Inc. · 2022
- 1 generation backK230854 SwiftMRAirs Medical, Inc. · 2023
- This deviceK243250 SubtleHD (1.x)Subtle Medical, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| −7 | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| −6 | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| −5 | K172768 | ZOOM | Zetta Medical Technologies, LLC | 2018 | — |
| −4 | K191688 | SubtleMR | Subtle Medical, Inc. | 2019 | — |
| −3 | K210999 | SwiftMR | Airs Medical, Inc. | 2021 | — |
| −2 | K220416 | SwiftMR | Airs Medical, Inc. | 2022 | — |
| −1 | K230854 | SwiftMR | Airs Medical, Inc. | 2023 | — |
| 0 (this device) | K243250 | SubtleHD (1.x) | Subtle Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 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 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? (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 |
|---|---|---|---|
| * | K230854 | SwiftMRSummary page 5…892.2050 Product Code: QIH Device Class: Class II Legally Marketed Predicate Devices: Primary Predicate #: K230854 Predicate Trade Name: SwiftMR Predicate Manufactu… | 2023 |
| * | K223623 | SubtleMR (2.3.x)Summary page 5…ate Trade Name: SwiftMR Predicate Manufacturer: AIRS Medical Inc. Secondary Predicate #: K223623 Predicate Trade Name: SubtleMR Predicate Manufact… | 2023 |
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 33 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K230854.
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. 2025, 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?
SubtleHD is an image processing software that can be used for image enhancement of all body parts MRI images. It can be used for noise reduction and increasing image sharpness.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243250 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243250: SubtleHD (1.x).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243250
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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