Cleared Traditional

K181413 - uDR 592h

K181413 is the FDA 510(k) clearance for uDR 592h by Shanghai United Imaging Healthcare Co., Ltd.. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K181413 · Shanghai United Imaging Healthcare Co., Ltd. · Radiology device
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Jun 2018
Decision
28d
Days
Class 2
Risk

K181413 is an FDA 510(k) clearance for the uDR 592h, uDR 596i. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Shanghai United Imaging Healthcare Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on June 27, 2018 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 K181413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2018
Decision Date June 27, 2018
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 164
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