Cleared Traditional

K173622 - CS Imaging

K173622 is the FDA 510(k) clearance for CS Imaging by Trophy. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K173622 · Trophy · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
53d
Days
Class 2
Risk

K173622 is an FDA 510(k) clearance for the CS Imaging. 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 Trophy (Croissy-Beaubourg, FR). The FDA issued a Cleared decision on January 16, 2018 after a review of 53 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 Trophy devices

Submission Details

510(k) Number K173622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2017
Decision Date January 16, 2018
Days to Decision 53 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 107d · This submission: 53d
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 1056
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K173622.
Vitrea Software Toshiba Package VSTP-001A
K173088 · Toshibamedical Systems Corporation · Jan 2018
Arterys Oncology DL
K173542 · Arterys, Inc. · Jan 2018
Navigo Workstation Version 2.0
K173054 · UC-CARE , Ltd. · Jan 2018
Illumeo System
K173588 · Philips Medical Systems Technologies , Ltd. · Jan 2018
DTX Studio diagnose
K172224 · Nobel Biocare AB · Jan 2018
cNeuro cMRI
K171328 · Combinostics OY · Jan 2018