Cleared Traditional

K173953 - uDR 780i

K173953 is the FDA 510(k) clearance for uDR 780i 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 30-day FDA review.

K173953 · Shanghai United Imaging Healthcare Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
30d
Days
Class 2
Risk

K173953 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 January 26, 2018 after a review of 30 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 K173953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2017
Decision Date January 26, 2018
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
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
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K173953.
Televere Podiatry X-Ray System HF
K180765 · Televere Systems, Inc. · Apr 2018
RADspeed fit
K173517 · Shimadzu Corporation · Mar 2018
Amrad Medical AAU Digital Radiography System
K173823 · Summit Industries, LLC · Feb 2018
GU60A & GU60A-65
K173828 · Samsung Electronics Co., Ltd. · Jan 2018
GC85A
K172229 · Samsung Electronics Co., Ltd. · Nov 2017
Carestream DRX-Evolution
K163203 · Carestream Health, Inc. · Dec 2016