uMI Panvivo (uMI Panvivo M)
K-Number: K261427 · 2026-07-28
Device Summary
Frequently Asked Questions
What is the uMI Panvivo (uMI Panvivo M)?
uMI Panvivo (uMI Panvivo M) is a medical device that received FDA 510(k) clearance on 2026-07-28. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K261427.
When did uMI Panvivo (uMI Panvivo M) receive FDA 510(k) clearance?
uMI Panvivo (uMI Panvivo M) received FDA 510(k) clearance on 2026-07-28, under 510(k) number K261427.
Who is the listed applicant for uMI Panvivo (uMI Panvivo M)?
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 (uMI Panvivo M)?
The FDA product code for uMI Panvivo (uMI Panvivo M) 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.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.