Cleared Traditional

K260524 - uMI Panvivo (uMI Panvivo LS)

Also marketed or referenced as:
uMI Panvivo (uMI Panvivo) uMI Panvivo (uMI Panvivo S) uMI Panvivo (uMI Panvivo EX) uMI Panvivo (uMI Panvivo ES)

K260524 is the FDA 510(k) clearance for uMI Panvivo (uMI Panvivo LS) by Shanghai United Imaging Healthcare Co., Ltd.. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K260524 · Shanghai United Imaging Healthcare Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
45d
Days
Class 2
Risk

K260524 is an FDA 510(k) clearance for the uMI Panvivo (uMI Panvivo LS). Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Shanghai United Imaging Healthcare Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on April 3, 2026 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shanghai United Imaging Healthcare Co., Ltd. devices

Submission Details

510(k) Number K260524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2026
Decision Date April 03, 2026
Days to Decision 45 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 107d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 242
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K260524.
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