Cleared Traditional

K102435 - BEYONDIMAGE WORKSTATION

K102435 is an FDA 510(k) clearance for BEYONDIMAGE WORKSTATION, manufactured by Neusoft Medical Systems Co., Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K102435 · Neusoft Medical Systems Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
50d
Days
Class 2
Risk

K102435 is an FDA 510(k) clearance for the BEYONDIMAGE WORKSTATION. 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 Neusoft Medical Systems Co., Ltd. (Shenyang, Liaoning, CN). The FDA issued a Cleared decision on October 15, 2010 after a review of 50 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 Neusoft Medical Systems Co., Ltd. devices

FDA 510(k) Submission Details - K102435

510(k) Number K102435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2010
Decision Date October 15, 2010
Days to Decision 50 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
57d faster than avg
Panel avg: 107d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

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 1192
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K102435.
Q-STATION
K103815 · Philips Ultrasound, Inc. · Jan 2011
TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K103182 · Genoray Co., Ltd. · Jan 2011
20.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A)
K092728 · Totoku Electric Co., Ltd. · Nov 2010
4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ
K101166 · Ge Healthcare · Oct 2010
SYNGO DYNAMICS, VERSION 9.0
K102150 · Siemens Medical Solutions USA, Inc. · Oct 2010
EP NAVIGATOR R3
K101311 · Philips Medical Systems North America Co. · Sep 2010