510(k) · Cleared
ClearedSharpview 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 18, 2000 as substantially equivalent to K922470 (Open Mri, Inc., 1992) after a 70-day review. Its family tree reaches back 1 generation to 1992. 120 later devices descend from it.
- Decided
- Jan 18, 2000
- Review
- 70 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922470 (1992). 120 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- This deviceK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- Descendant · cites it directly · 106 of its ownK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- Descendant · 2 generations on · 64 of its ownK052355 Automated Breast Ultrasound System, Model AbusU-Systems, Inc. · 2005
- Descendant · 3 generations on · 53 of its ownK080555 Sofia Automated Tomographic Ultrasound (Atus)Ivu Imaging Corporation · 2008
- Descendant · 4 generations on · 50 of its ownK123209 SoftvueDelphinus Medical Technologies, Inc. · 2013
- Descendant · 5 generations on · 49 of its ownK142517 SoftVueDelphinus Medical Technologies, Inc. · 2014
Showing 5 of 120 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 120 · See all- K024028Sharp View Image Enhancement SystemContext Vision AB · 2003 · cites it directly106descendants
- K052355Automated Breast Ultrasound System, Model AbusU-Systems, Inc. · 2005 · 2 generations on64descendants
- K080555Sofia Automated Tomographic Ultrasound (Atus)Ivu Imaging Corporation · 2008 · 3 generations on53descendants
- K123209SoftvueDelphinus Medical Technologies, Inc. · 2013 · 4 generations on50descendants
- K142517SoftVueDelphinus Medical Technologies, Inc. · 2014 · 5 generations on49descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| 0 (this device) | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| +1 | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| +2 | K052355 | Automated Breast Ultrasound System, Model Abus | U-Systems, Inc. | 2005 | — |
| +3 | K080555 | Sofia Automated Tomographic Ultrasound (Atus) | Ivu Imaging Corporation | 2008 | — |
| +4 | K123209 | Softvue | Delphinus Medical Technologies, Inc. | 2013 | — |
| +5 | K142517 | SoftVue | Delphinus Medical Technologies, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 9 | 0 |
| 2019 | 6 | 0 |
| 2020 | 6 | 0 |
| 2021 | 13 | 0 |
| 2022 | 7 | 0 |
| 2023 | 10 | 0 |
| 2024 | 12 | 0 |
| 2025 | 11 | 0 |
| 2026 | 16 | 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 |
|---|---|---|---|
| * | K922470 | Ies, Image Enhancement SystemSummary page 1…mon/Usual Name: MRI Image Enhancement System 2. Equivalent legally marketed devices: This product is similar in design and function to the IES Image Enhancement System, K922470 3. Indications for Use (intended use) The SharpView Image Enhancement System is used for the intended for use by a qualified/tra… | 1992 |
What descends from it? (120)
See all 1205 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?
- Its one ancestor has no recall.
- Of its descendants, K024028 (Context Vision AB, 2003) has gone furthest, with 106 descendants of its own.
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 MRI images.
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/K993802 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993802: Sharpview Image Enhancement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993802
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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