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FDA 510(k)

ThinkSono Guidance

K-Number: K260338 · 2026-07-15

Decision Date2026-07-15
Product CodeQJU
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ThinkSono Guidance is the device name listed in this FDA 510(k) record. The listed applicant is ThinkSono GmbH. It received FDA 510(k) clearance on 2026-07-15 under 510(k) number K260338. The device is classified under product code QJU. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ThinkSono Guidance?

ThinkSono Guidance is a medical device that received FDA 510(k) clearance on 2026-07-15. The listed applicant is ThinkSono GmbH. The 510(k) number is K260338.

When did ThinkSono Guidance receive FDA 510(k) clearance?

ThinkSono Guidance received FDA 510(k) clearance on 2026-07-15, under 510(k) number K260338.

Who is the listed applicant for ThinkSono Guidance?

The FDA 510(k) record lists ThinkSono GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ThinkSono Guidance?

The FDA product code for ThinkSono Guidance is QJU.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: QJU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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