FDA product code LSY: Ultrasound, Hyperthermia, Cancer Treatment
LSY is the FDA product code for ultrasound, hyperthermia, cancer treatment. It is a Class III device, reviewed by the Radiology panel. Devices under LSY reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Ultrasound, Hyperthermia, Cancer Treatment |
| Device class | Class III |
| Review panel | RA — Radiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LSY devices
openFDA lists no recalls for product code LSY.
Frequently asked questions
What is FDA product code LSY?
LSY is the FDA product code for ultrasound, hyperthermia, cancer treatment. It is a Class III device, reviewed by the Radiology panel.
What device class is LSY?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LSY
- Run a recall and safety report across every LSY manufacturer
- Watch product code LSY 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.