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FDA 510(k)

PIUR tUS inside

K-Number: K250484 · 2025-06-30

ApplicantPiur Imaging GmbH
Decision Date2025-06-30
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PIUR tUS inside is the device name listed in this FDA 510(k) record. The listed applicant is Piur Imaging GmbH. It received FDA 510(k) clearance on 2025-06-30 under 510(k) number K250484. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIUR tUS inside?

PIUR tUS inside is a medical device that received FDA 510(k) clearance on 2025-06-30. The listed applicant is Piur Imaging GmbH. The 510(k) number is K250484.

When did PIUR tUS inside receive FDA 510(k) clearance?

PIUR tUS inside received FDA 510(k) clearance on 2025-06-30, under 510(k) number K250484.

Who is the listed applicant for PIUR tUS inside?

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

What is the FDA product code for PIUR tUS inside?

The FDA product code for PIUR tUS inside is QIH.

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.

NCT05134311Examining the Use of Three Dimensional Ultrasound in the Assessment of Vascular PathologiesRECRUITING

Other records listing Piur Imaging GmbH as applicant

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.

K240036PIUR tUS Infinity

Related Devices (Code: QIH)

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.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.

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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