ThinkSono Guidance— 510(k) K260338
Substantially EquivalentThinkSono GmbH
FDA 510(k) clearance K260338 for ThinkSono Guidance, Substantially Equivalent on 2026-07-15. Applicant: ThinkSono GmbH. Device class: 2.
Summary
ThinkSono Guidance from ThinkSono is filed under QJU, image acquisition and/or optimization guided by artificial intelligence. The record doesn't say which imaging the product guides.
Class II, 21 CFR 892.2100. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
ThinkSono filed from Potsdam, Germany. The decision came 163 calendar days after FDA received it (February 2 to July 15, 2026).
Clearance details
- Applicant
- ThinkSono GmbH
- Product code
- Product code QJU
- Device class
- Class 2
- Regulation
- 21 CFR 892.2100
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Potsdam, DE
Recent devices under product code QJU
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