Cleared Traditional

K172135 - uCT Computed Tomography X-ray System

K172135 is the FDA 510(k) clearance for uCT Computed Tomography X-ray System by Shanghai United Imaging Healthcare Co., Ltd.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K172135 · Shanghai United Imaging Healthcare Co., Ltd. · Radiology device
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Mar 2018
Decision
231d
Days
Class 2
Risk

K172135 is an FDA 510(k) clearance for the uCT Computed Tomography X-ray System. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Shanghai United Imaging Healthcare Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on March 2, 2018 after a review of 231 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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

Submission Details

510(k) Number K172135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2017
Decision Date March 02, 2018
Days to Decision 231 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
124d slower than avg
Panel avg: 107d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 581
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