Cleared Traditional

K162141 - Restore PACS (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K162141 · Xian Wingspan Electronic Technology Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
32d
Days
Class 2
Risk

K162141 is an FDA 510(k) clearance for the Restore PACS. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Xian Wingspan Electronic Technology Co., Ltd. (Xi'An, CN). The FDA issued a Cleared decision on September 2, 2016 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Xian Wingspan Electronic Technology Co., Ltd. devices

Submission Details

510(k) Number K162141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2016
Decision Date September 02, 2016
Days to Decision 32 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 107d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 2262
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K162141.
LungPoint Virtual Bronchoscopic Navigation (VBN) Software
K260009 · Broncus Medical, Inc. · Apr 2026
CCI PACS VIEWER (PACS-US-001)
K254237 · CliniComp, Intl. · Apr 2026
ARTICOR planner
K252195 · Artiness S.R.L · Mar 2026
TheraSphere 360™ Y-90 Management Platform
K260479 · Boston Scientific Corporation · Mar 2026
Aeka Imaging
K253111 · Good Methods Global, Inc. · Mar 2026
Mimics Thoracic Planner
K251964 · Materialise NV · Mar 2026