Cleared Traditional

IMAGE STORAGE SYSTEM, MODEL KSS-400

K081797 · Konan Medical, Inc. · Ophthalmic

Jan 2009

Decision

211d

Days

Class 2

Risk

About This 510(k) Submission

K081797 is an FDA 510(k) clearance for the IMAGE STORAGE SYSTEM, MODEL KSS-400, a System, Image Management, Ophthalmic (Class II — Special Controls, product code NFJ), submitted by Konan Medical, Inc. (Hasbrouck Heights, US). The FDA issued a Cleared decision on January 22, 2009, 211 days after receiving the submission on June 25, 2008. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K081797 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 25, 2008
Decision Date	January 22, 2009
Days to Decision	211 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF