K260338
- 510(k) number
- K260338
- Device name
- ThinkSono Guidance
- Applicant
- ThinkSono GmbH DE
- Product code
- QJU — Image Acquisition And/Or Optimization Guided By Arti
- Decision date
- 2026-07-15
- Date received
- 2026-02-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K260338.pdf
Official FDA record: K260338
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.