Cleared Traditional

MULTIPLE ED1600 SERIES RADIATION SHIELDS

K944772 · Image Diagnostics, Inc. · Radiology

Oct 1994

Decision

23d

Days

Class 1

Risk

About This 510(k) Submission

K944772 is an FDA 510(k) clearance for the MULTIPLE ED1600 SERIES RADIATION SHIELDS, a Screen, Leaded, Operator Radiation Protector (Class I — General Controls, product code EAK), submitted by Image Diagnostics, Inc. (Sterling, US). The FDA issued a Cleared decision on October 20, 1994, 23 days after receiving the submission on September 27, 1994. This device falls under the Radiology review panel. Regulated under 21 CFR 892.6500.

Submission Details

510(k) Number	K944772 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 1994
Decision Date	October 20, 1994
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF