Cleared Traditional

IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM

K971685 · Tomey Corporation USA · Ophthalmic
Jun 1997
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K971685 is an FDA 510(k) clearance for the IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Tomey Corporation USA (Washington, US). The FDA issued a Cleared decision on June 24, 1997, 48 days after receiving the submission on May 7, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K971685 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 1997
Decision Date June 24, 1997
Days to Decision 48 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKI — Camera, Ophthalmic, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1120