510(k) · Cleared
ClearedQca Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sanders Data Systems, LLC · LLZ System, Image Processing, Radiological
Cleared on Jan 24, 1992 after a 45-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Jan 24, 1992
- Review
- 45 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK915542 Qca PlusSanders Data Systems, LLC · 1992
- Descendant · cites it directly · 4 of its ownK100849 Sync-RX System, Model AS00010Sync-Rx, Ltd. · 2010
- Descendant · 2 generations on · 3 of its ownK132558 Sync-RX SystemVolcano Corporation · 2013 · Recalled
- Descendant · 3 generations on · 2 of its ownK151904 SyncVision SystemVolcano Corporation · 2015 · Recalled
- Descendant · 4 generations on · 1 of its ownK161756 SyncVision SystemVolcano Corporation · 2016 · Recalled
- Descendant · 5 generations on · 0 of its ownK172574 SyncVision SystemVolcano Corporation · 2017 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K100849Sync-RX System, Model AS00010Sync-Rx, Ltd. · 2010 · cites it directly4descendants
- K132558Sync-RX SystemVolcano Corporation · 2013 · 2 generations on3descendants
- K151904SyncVision SystemVolcano Corporation · 2015 · 3 generations on2descendants
- K161756SyncVision SystemVolcano Corporation · 2016 · 4 generations on1descendant
- K172574SyncVision SystemVolcano Corporation · 2017 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915542 | Qca Plus | Sanders Data Systems, LLC | 1992 | — |
| +1 | K100849 | Sync-RX System, Model AS00010 | Sync-Rx, Ltd. | 2010 | — |
| +2 | K132558 | Sync-RX System | Volcano Corporation | 2013 | 1 |
| +3 | K151904 | SyncVision System | Volcano Corporation | 2015 | 1 |
| +4 | K161756 | SyncVision System | Volcano Corporation | 2016 | 1 |
| +5 | K172574 | SyncVision System | Volcano Corporation | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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?
The FDA summary names no predicate by number.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100849 | Sync-RX System, Model AS00010 | 2010 | 4 |
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?
- Of its descendants, K100849 (Sync-Rx, Ltd., 2010) has gone furthest, with 4 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 intended applications of the software are: 1. In clinical trials evaluating the effectiveness in treating coronary artery disease of therapies such as interventional devices, drugs or changes in lifestyle. Such trials incorporate data from many sources and are subject to intense scrutiny and statistical validation. 2. In diagnosing and evaluating the need for therapy of a patient with coronary artery disease. In such an application, the software…
Read the full statement (169 words)
The intended applications of the software are:
1. In clinical trials evaluating the effectiveness in treating coronary artery disease of therapies such as interventional devices, drugs or changes in lifestyle. Such trials incorporate data from many sources and are subject to intense scrutiny and statistical validation.
2. In diagnosing and evaluating the need for therapy of a patient with coronary artery disease. In such an application, the software provides data only and does not perform diagnosis. A decision regarding the need for therapy is multi-factorial, -d6pen& pitferinsymptoms, -historyand the results of multiple laboratory tests. The clinical judgement and experience of the physician is used to interpret and evaluate all of the data prior to making a diagnosis or therapy decision.
3. In evaluating the effectiveness of therapy for an individual patient. Again, the software provides data only and does not perform diagnosis. The effectiveness of the therapy in terms of symptomatic relief and the results of other laboratory tests are also evaluated by the physician in making a decision.
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/K915542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K915542: Qca Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915542
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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