510(k) · Cleared
ClearedZia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zetta Medical Technologies, LLC · LLZ System, Image Processing, Radiological
Cleared on Dec 15, 2016 as substantially equivalent to K024028 (Context Vision AB, 2003) after a 262-day review. Its family tree reaches back 3 generations to 1992. 4 later devices descend from it.
- Decided
- Dec 15, 2016
- Review
- 262 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922470 (1992). 4 later devices descend from it, 1 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 deviceK160852 ZiaZetta Medical Technologies, LLC · 2016
- Descendant · cites it directly · 3 of its ownK183460 ClariCT.AIClaripi, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK212074 ClariCT.AIClaripi, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK254120 SubtleHD-CT (1.x)Subtle Medical, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK244002 AngioWaveNetAngiowave Imaging, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See allView 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) | K160852 | Zia | Zetta Medical Technologies, LLC | 2016 | — |
| +1 | K183460 | ClariCT.AI | Claripi, Inc. | 2019 | — |
| +2 | K212074 | ClariCT.AI | Claripi, Inc. | 2021 | — |
| +3 | K254120 | SubtleHD-CT (1.x) | Subtle Medical, Inc. | 2026 | — |
| +3 | K244002 | AngioWaveNet | Angiowave Imaging, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 4…Regulatory Description: Picture Archiving and Communications System 3. Predicate Device: Context Vision Sharp View Image Enhancement System, K024028 4. Indications for Use: Zia™ Image Enhancement System is an image processing software that can be used… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183460 | ClariCT.AI | 2019 | 3 |
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 24 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K183460 (Claripi, Inc., 2019) has gone furthest, with 3 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. 2016, 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?
Zia™ Image Enhancement System is an image processing software that can be used for reducing noise in CT images.
Enhanced images will be uploaded back to host/PACS systems and exist in conjunction to the original images. Zia™ is not intended for mammography applications. The device processing is not effective for lesion, mass, or abnormalities of sizes less than 2mm.
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/K160852 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160852: Zia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160852
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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