Cleared Traditional

LASER IMAGING WORK STATION

K897186 · Innovision Medical, Inc. · Ophthalmic

Mar 1990

Decision

74d

Days

Class 1

Risk

About This 510(k) Submission

K897186 is an FDA 510(k) clearance for the LASER IMAGING WORK STATION, a Lens, Fundus, Hruby, Diagnostic (Class I — General Controls, product code HJI), submitted by Innovision Medical, Inc. (Washington, US). The FDA issued a Cleared decision on March 12, 1990, 74 days after receiving the submission on December 28, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1395.

Submission Details

510(k) Number	K897186 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 28, 1989
Decision Date	March 12, 1990
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—