QGM
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4405
- Medical specialty
- General, Plastic Surgery
- FDA definition
- This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue.
- Adverse events (MAUDE)
- 2025: 43 · 2026: 37
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Edison System (K241902) | HistoSonics, Inc. | 2024-10-30 |
| Edison System (K233466) | HistoSonics, Inc. | 2024-03-13 |
| Edison System (DEN220087) | HistoSonics, Inc. | 2023-10-06 |
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Every clearance here is in the API, with alerts when new ones post.