Cleared Traditional

K241068 - uDR 780i

K241068 is an FDA 510(k) clearance for uDR 780i, manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K241068 · Shanghai United Imaging Healthcare Co., Ltd. · Radiology device
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Nov 2024
Decision
196d
Days
Class 2
Risk

K241068 is an FDA 510(k) clearance for the uDR 780i. 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 November 1, 2024 after a review of 196 days - an extended review 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: 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

FDA 510(k) Submission Details - K241068

510(k) Number K241068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2024
Decision Date November 01, 2024
Days to Decision 196 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
89d slower than avg
Panel avg: 107d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

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 262
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