510(k) · Cleared
ClearedSubtleHD-PET (1.x)
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 May 14, 2026 as substantially equivalent to K213140 (Claritas Healthtech Pte, Ltd., 2021) and 1 other predicate after a 150-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- May 14, 2026
- Review
- 150 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K922470 (1992). 7 ancestors in all. No later device cites it as a predicate yet.
- 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 backK063391 Sapheneia ClaritySapheneia Commercial Products AB · 2007
- 2 generations backK182336 SubtlePETSubtle Medical, Inc. · 2018
- 1 generation backK211964 SubtlePETSubtle Medical, Inc. · 2021
- This deviceK254013 SubtleHD-PET (1.x)Subtle Medical, Inc. · 2026
View 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 | K063391 | Sapheneia Clarity | Sapheneia Commercial Products AB | 2007 | — |
| −2 | K182336 | SubtlePET | Subtle Medical, Inc. | 2018 | — |
| −1 | K211964 | SubtlePET | Subtle Medical, Inc. | 2021 | — |
| 0 (this device) | K254013 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 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? (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 |
|---|---|---|---|
| * | K213140 | Claritas iPETSummary page 5…er: 892.2050 Product Code: LLZ Device Class: Class II Legally Marketed Predicate Primary Predicate #: K213140 Devices: Primary Predicate Name: Claritas iPET Primary Predicate Leg… | 2021 |
| * | K211964 | SubtlePETSummary page 5…Primary Predicate Legal Manufacturer: Claritas Healthtech Pte, Ltd. Secondary Predicate #: K211964 Secondary Predicate Name: SubtlePET Secondary Predicate Leg… | 2021 |
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 4 companies; a new generation was cleared every 4.6 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K213140.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
SubtleHD-PET is an image processing software intended for noise reduction of PET images (including PET/CT and PET/MR) obtained with any kind of radiotracer (e.g. 18F-FDG).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254013: SubtleHD-PET (1.x).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254013
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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