Cleared Traditional

RETINAL CUBE

K973950 · Applied Spectral Imaging , Ltd. · Ophthalmic
Dec 1997
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K973950 is an FDA 510(k) clearance for the RETINAL CUBE, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Applied Spectral Imaging , Ltd. (Migdal Ha'Emek, IL). The FDA issued a Cleared decision on December 12, 1997, 57 days after receiving the submission on October 16, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K973950 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 1997
Decision Date December 12, 1997
Days to Decision 57 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