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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 the device name listed in this FDA 510(k) record. The listed applicant is This AG. It received FDA 510(k) clearance on 2025-11-14 under 510(k) 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. The listed applicant is This AG. The 510(k) number is K250501.

When did System Sophi receive FDA 510(k) clearance?

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

Who is the listed applicant for System Sophi?

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

What is the FDA product code for System Sophi?

The FDA product code for System Sophi is HQC.

Related Devices (Code: HQC)

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.

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Official Source

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

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