# K915542: Qca Plus

- Pathway: 510(k) (Traditional)
- Applicant: Sanders Data Systems, LLC
- Decided: Jan 24, 1992 after 45 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K100849: Sync-RX System, Model AS00010 (2010), 4 descendants of its own
- K132558: Sync-RX System (2013), 3 descendants of its own
- K151904: SyncVision System (2015), 2 descendants of its own
- K161756: SyncVision System (2016), 1 descendant of its own
- K172574: SyncVision System (2017), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K915542
Methodology: https://510kreport.com/methodology