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FDA 510(k)

uMI Panvivo

K-Number: K241596 · 2024-08-15

Decision Date2024-08-15
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uMI Panvivo is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2024-08-15 under 510(k) number K241596. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the uMI Panvivo?

uMI Panvivo is a medical device that received FDA 510(k) clearance on 2024-08-15. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K241596.

When did uMI Panvivo receive FDA 510(k) clearance?

uMI Panvivo received FDA 510(k) clearance on 2024-08-15, under 510(k) number K241596.

Who is the listed applicant for uMI Panvivo?

The FDA 510(k) record lists Shanghai United Imaging Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for uMI Panvivo?

The FDA product code for uMI Panvivo is KPS.

Other records listing Shanghai United Imaging Healthcare Co., Ltd. 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.

View all 84 devices →

Related Devices (Code: KPS)

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