510(k) · Cleared
ClearedSubtleMR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Subtle Medical, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 16, 2019 as substantially equivalent to K172768 (Zetta Medical Technologies, LLC, 2018) after an 84-day review. Its family tree reaches back 4 generations to 1992. 20 later devices descend from it.
- Decided
- Sep 16, 2019
- Review
- 84 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K922470 (1992). 20 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 3 generations backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- 2 generations backK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- 1 generation backK172768 ZOOMZetta Medical Technologies, LLC · 2018
- This deviceK191688 SubtleMRSubtle Medical, Inc. · 2019
- Descendant · cites it directly · 6 of its ownK210999 SwiftMRAirs Medical, Inc. · 2021
- Descendant · cites it directly · 6 of its ownK203182 SubtleMRSubtle Medical, Inc. · 2021
- Descendant · cites it directly · 5 of its ownK202404 BoneMRIMriguidance B.V. · 2021
- Descendant · 2 generations on · 4 of its ownK221762 BoneMRI v1.4Mrlguidance B.V. · 2022
- Descendant · 2 generations on · 4 of its ownK220416 SwiftMRAirs Medical, Inc. · 2022
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K210999SwiftMRAirs Medical, Inc. · 2021 · cites it directly6descendants
- K203182SubtleMRSubtle Medical, Inc. · 2021 · cites it directly6descendants
- K202404BoneMRIMriguidance B.V. · 2021 · cites it directly5descendants
- K221762BoneMRI v1.4Mrlguidance B.V. · 2022 · 2 generations on4descendants
- K220416SwiftMRAirs Medical, Inc. · 2022 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| −3 | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| −2 | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| −1 | K172768 | ZOOM | Zetta Medical Technologies, LLC | 2018 | — |
| 0 (this device) | K191688 | SubtleMR | Subtle Medical, Inc. | 2019 | — |
| +1 | K210999 | SwiftMR | Airs Medical, Inc. | 2021 | — |
| +1 | K203182 | SubtleMR | Subtle Medical, Inc. | 2021 | — |
| +1 | K202404 | BoneMRI | Mriguidance B.V. | 2021 | — |
| +2 | K221762 | BoneMRI v1.4 | Mrlguidance B.V. | 2022 | — |
| +2 | K220416 | SwiftMR | Airs Medical, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K172768 | ZOOMSummary page 4…gical Device Class: Class II Product Code: LLZ 510(k) Number: K172768 510(k) Clearance Date: April 24, 2018 Main Text… | 2018 |
What descends from it? (20)
See all 204 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 27 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K210999 (Airs Medical, Inc., 2021) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K172768.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head, spine, neck and knee MRI, or increase image sharpness for non-contrast enhanced head MRI.
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/K191688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191688: SubtleMR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191688
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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