510(k) · Cleared
ClearedSapheneia Clarity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sapheneia Commercial Products AB · LLZ System, Image Processing, Radiological
Cleared on Apr 26, 2007 as substantially equivalent to K024028 (Context Vision AB, 2003) after a 168-day review. Its family tree reaches back 3 generations to 1992. 9 later devices descend from it.
- Decided
- Apr 26, 2007
- Review
- 168 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922470 (1992). 9 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 2 generations backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- 1 generation backK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- This deviceK063391 Sapheneia ClaritySapheneia Commercial Products AB · 2007
- Descendant · cites it directly · 5 of its ownK182336 SubtlePETSubtle Medical, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK213140 Claritas iPETClaritas Healthtech Pte, Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK211964 SubtlePETSubtle Medical, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK261305 Micsi-PetMicrostructure Imaging, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK254013 SubtleHD-PET (1.x)Subtle Medical, Inc. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K182336SubtlePETSubtle Medical, Inc. · 2018 · cites it directly5descendants
- K213140Claritas iPETClaritas Healthtech Pte, Ltd. · 2021 · 2 generations on2descendants
- K211964SubtlePETSubtle Medical, Inc. · 2021 · 2 generations on2descendants
- K261305Micsi-PetMicrostructure Imaging, Inc. · 2026 · 3 generations on0descendants
- K254013SubtleHD-PET (1.x)Subtle Medical, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| −2 | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| −1 | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| 0 (this device) | K063391 | Sapheneia Clarity | Sapheneia Commercial Products AB | 2007 | — |
| +1 | K182336 | SubtlePET | Subtle Medical, Inc. | 2018 | — |
| +2 | K213140 | Claritas iPET | Claritas Healthtech Pte, Ltd. | 2021 | — |
| +2 | K211964 | SubtlePET | Subtle Medical, Inc. | 2021 | — |
| +3 | K261305 | Micsi-Pet | Microstructure Imaging, Inc. | 2026 | — |
| +3 | K254013 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 3 | 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 |
|---|---|---|---|
| * | K024028 | Sharp View Image Enhancement SystemSummary page 2…istics for Sapheneia ClarityTM are substantially equivalent to the predicate device named ContextVision AB, ShaMView IragR Frnhancement System (K024028). ContextVision AB, SharpView Image Enhancement System (K024028) is an image transfer, enhancement, an… | 2003 |
What descends from it? (9)
4 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 15 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K182336 (Subtle Medical, Inc., 2018) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K024028.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The Sapheneia Clarity is intended for use by radiologists for transfer, storage, noise reduction, contrast enhancement and viewing of multi-modality images from a variety of diagnostic systems. The device is also intended to be used by trained/qualified technologists for installation and maintenance of the software. For your legal protection, it is strongly recommended that you backup your original data.
For digital mammography, only DICOM 'For Presentation' images should be displayed for primary image diagnosis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063391 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063391: Sapheneia Clarity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063391
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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