K233466
- 510(k) number
- K233466
- Device name
- Edison System
- Applicant
- HistoSonics, Inc. MN · US
- Product code
- QGM — Focused Ultrasound System For Non-Thermal, Mechanica
- Decision date
- 2024-03-13
- Date received
- 2023-10-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K233466.pdf
Official FDA record: K233466
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.