Cleared Traditional

K251839 - uMI Panvivo (uMI Panvivo) (FDA 510(k) Clearance)

Also includes:
uMI Panvivo (uMI Panvivo S)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251839 · Shanghai United Imaging Healthcare Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
31d
Days
Class 2
Risk

K251839 is an FDA 510(k) clearance for the uMI Panvivo (uMI Panvivo). 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 July 17, 2025 after a review of 31 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 K251839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2025
Decision Date July 17, 2025
Days to Decision 31 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
76d faster than avg
Panel avg: 107d · This submission: 31d
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 469
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K251839.
uMI Panvivo (uMI Panvivo LS)
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