510(k) · Cleared
ClearedSharp View Image Enhancement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Context Vision AB · LLZ System, Image Processing, Radiological
Cleared on Jan 24, 2003 as substantially equivalent to K993802 (Context Vision AB, 2000) after a 49-day review. Its family tree reaches back 2 generations to 1992. 106 later devices descend from it.
- Decided
- Jan 24, 2003
- Review
- 49 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922470 (1992). 106 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 1 generation backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- This deviceK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- Descendant · cites it directly · 64 of its ownK052355 Automated Breast Ultrasound System, Model AbusU-Systems, Inc. · 2005
- Descendant · 2 generations on · 53 of its ownK080555 Sofia Automated Tomographic Ultrasound (Atus)Ivu Imaging Corporation · 2008
- Descendant · 3 generations on · 50 of its ownK123209 SoftvueDelphinus Medical Technologies, Inc. · 2013
- Descendant · 4 generations on · 49 of its ownK142517 SoftVueDelphinus Medical Technologies, Inc. · 2014
- Descendant · 5 generations on · 42 of its ownK150949 FibroScanEchosens · 2015
Showing 5 of 106 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 106 · See all- K052355Automated Breast Ultrasound System, Model AbusU-Systems, Inc. · 2005 · cites it directly64descendants
- K080555Sofia Automated Tomographic Ultrasound (Atus)Ivu Imaging Corporation · 2008 · 2 generations on53descendants
- K123209SoftvueDelphinus Medical Technologies, Inc. · 2013 · 3 generations on50descendants
- K142517SoftVueDelphinus Medical Technologies, Inc. · 2014 · 4 generations on49descendants
- K150949FibroScanEchosens · 2015 · 5 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| −1 | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| 0 (this device) | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| +1 | K052355 | Automated Breast Ultrasound System, Model Abus | U-Systems, Inc. | 2005 | — |
| +2 | K080555 | Sofia Automated Tomographic Ultrasound (Atus) | Ivu Imaging Corporation | 2008 | — |
| +3 | K123209 | Softvue | Delphinus Medical Technologies, Inc. | 2013 | — |
| +4 | K142517 | SoftVue | Delphinus Medical Technologies, Inc. | 2014 | — |
| +5 | K150949 | FibroScan | Echosens | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 8 | 0 |
| 2019 | 6 | 0 |
| 2020 | 6 | 0 |
| 2021 | 12 | 0 |
| 2022 | 7 | 0 |
| 2023 | 9 | 0 |
| 2024 | 10 | 0 |
| 2025 | 10 | 0 |
| 2026 | 14 | 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 |
|---|---|---|---|
| * | K993802 | Sharpview Image Enhancement SystemSummary page 1…e Enhancement System 2. Equtvnlent legally mxketed devices: This product is similx in design m d function to the Contest\Ttsion Sharpl'tew Im,ige Enhancement System, K993802 3. Indications for Use (intended use); The SharpView Image Enhancement System IS intended for use by a qualified/traned techn… | 2000 |
What descends from it? (106)
See all 1067 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 11 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K052355 (U-Systems, Inc., 2005) has gone furthest, with 64 descendants of its own.
- 4 other devices also cite its predicate K993802.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 SharpView Image Enhancement System is intended for use by a qualified/trained technologist for transfer, storage, enhancement, and viewing of multi-modality images from a variety of diagnosis imaging systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024028 · printed Nov 4, 2026
Cite this page
510(k) Report. “K024028: Sharp View Image Enhancement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K024028
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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