Cleared Traditional

K911783 - ALLEGRO VIEWING WAND (FDA 510(k) Clearance)

K911783 · I.S.G. Technologies, Inc. · Radiology device

Apr 1994

Decision

1081d

Days

Class 2

Risk

K911783 is an FDA 510(k) clearance for the ALLEGRO VIEWING WAND. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by I.S.G. Technologies, Inc. (Mississauga Ontario, CA). The FDA issued a Cleared decision on April 7, 1994, 1081 days after receiving the submission on April 22, 1991.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K911783 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 22, 1991
Decision Date	April 07, 1994
Days to Decision	1081 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement