FDA product code QLL: Left Ventricular Ejection Fraction Screening Tool
QLL is the FDA product code for left ventricular ejection fraction screening tool. It is a Not classified device, reviewed by the Cardiovascular panel. Devices under QLL reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Electrocardiogram Low Ejection Fraction Tool to be used by healthcare professionals to provide an assessment of Left Ventricular Ejection Fraction (LVEF) for use as a diagnostic aid to screen for potential cardiac complications or underlying cardiac conditions, in adult patients. For use during declared public health emergency.
Classification
| Field | Value |
|---|---|
| Device name | Left Ventricular Ejection Fraction Screening Tool |
| Device class | Not classified |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QLL devices
openFDA lists no recalls for product code QLL.
Frequently asked questions
What is FDA product code QLL?
QLL is the FDA product code for left ventricular ejection fraction screening tool. It is a Not classified device, reviewed by the Cardiovascular panel.
What device class is QLL?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QLL
- Run a recall and safety report across every QLL manufacturer
- Watch product code QLL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.