Cleared Traditional

K183143 - uCT 520, uCT 528

K183143 is an FDA 510(k) clearance for uCT 520, manufactured by Shangai United Imaging Healthcare Co., Ltd.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K183143 · Shangai United Imaging Healthcare Co., Ltd. · Radiology device
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Jan 2019
Decision
51d
Days
Class 2
Risk

K183143 is an FDA 510(k) clearance for the uCT 520, uCT 528. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Shangai United Imaging Healthcare Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on January 3, 2019 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 Shangai United Imaging Healthcare Co., Ltd. devices

FDA 510(k) Submission Details - K183143

510(k) Number K183143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2018
Decision Date January 03, 2019
Days to Decision 51 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
56d faster than avg
Panel avg: 107d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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.

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