Cleared Traditional

CHASE CARDIAC ANALYSIS SYSTEM

K032531 · Chase Medical, Inc. · Radiology
Feb 2004
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K032531 is an FDA 510(k) clearance for the CHASE CARDIAC ANALYSIS SYSTEM, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Chase Medical, Inc. (Richardson, US). The FDA issued a Cleared decision on February 2, 2004, 171 days after receiving the submission on August 15, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K032531 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2003
Decision Date February 02, 2004
Days to Decision 171 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

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