Cleared Traditional

K922079 - ROTOLUX, SELECTOLUX, SHUTTERVUE
(FDA 510(k) Clearance)

K922079 · American Medical Sales, Inc. · Radiology device

Jun 1992

Decision

43d

Days

Class 1

Risk

K922079 is an FDA 510(k) clearance for the ROTOLUX, SELECTOLUX, SHUTTERVUE. This device is classified as a Illuminator, Radiographic-film (Class I - General Controls, product code IXC).

Submitted by American Medical Sales, Inc. (Culver City, US). The FDA issued a Cleared decision on June 16, 1992, 43 days after receiving the submission on May 4, 1992.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1890.

Submission Details

510(k) Number	K922079 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 04, 1992
Decision Date	June 16, 1992
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement