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FDA 510(k)

System Sophi

K-Number: K250501 · 2025-11-14

ApplicantThis AG
Decision Date2025-11-14
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

System Sophi is a medical device manufactured by This AG. It received FDA 510(k) clearance on 2025-11-14 under approval number K250501. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the System Sophi?

System Sophi is a medical device that received FDA 510(k) clearance on 2025-11-14. It is manufactured by This AG. The 510(k) number is K250501.

When was System Sophi approved by the FDA?

System Sophi received FDA 510(k) clearance on 2025-11-14, under approval number K250501.

What company makes System Sophi?

System Sophi is manufactured by This AG.

What is the FDA product code for System Sophi?

The FDA product code for System Sophi is HQC.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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