Cleared Traditional

K971176 - VIEW ARCHIVING STATION
(FDA 510(k) Clearance)

K971176 · Electromed Intl., Ltd. · Radiology

Sep 1997

Decision

156d

Days

Class 2

Risk

K971176 is an FDA 510(k) clearance for the VIEW ARCHIVING STATION, a System, X-ray, Angiographic (Class II — Special Controls, product code IZI), submitted by Electromed Intl., Ltd. (Quebec, CA). The FDA issued a Cleared decision on September 3, 1997, 156 days after receiving the submission on March 31, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1600.

Submission Details

510(k) Number	K971176 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 1997
Decision Date	September 03, 1997
Days to Decision	156 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF