Cleared Abbreviated

VIEW READING STATION

K003688 · Electromed Intl., Ltd. · Radiology

Jan 2001

Decision

53d

Days

Class 2

Risk

About This 510(k) Submission

K003688 is an FDA 510(k) clearance for the VIEW READING STATION, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Electromed Intl., Ltd. (St-Eustache, Quebec, CA). The FDA issued a Cleared decision on January 22, 2001, 53 days after receiving the submission on November 30, 2000. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K003688 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 30, 2000
Decision Date	January 22, 2001
Days to Decision	53 days
Submission Type	Abbreviated
Review Panel	Radiology (RA)
Summary	Summary PDF