Cleared Traditional

K193073 - Deep Recon

K193073 is the FDA 510(k) clearance for Deep Recon 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 245-day FDA review.

K193073 · Shanghai United Imaging Healthcare Co., Ltd. · Radiology device
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Jul 2020
Decision
245d
Days
Class 2
Risk

K193073 is an FDA 510(k) clearance for the Deep Recon. 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 July 6, 2020 after a review of 245 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 K193073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2019
Decision Date July 06, 2020
Days to Decision 245 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
138d slower than avg
Panel avg: 107d · This submission: 245d
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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