Cleared Traditional

WISE IMAGE MANAGEMENT SYSTEM

K971451 · O Tech, Inc. · Radiology

Jun 1997

Decision

66d

Days

Class 1

Risk

About This 510(k) Submission

K971451 is an FDA 510(k) clearance for the WISE IMAGE MANAGEMENT SYSTEM, a Device, Digital Image Storage, Radiological (Class I — General Controls, product code LMB), submitted by O Tech, Inc. (Plano, US). The FDA issued a Cleared decision on June 26, 1997, 66 days after receiving the submission on April 21, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2010.

Submission Details

510(k) Number	K971451 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 21, 1997
Decision Date	June 26, 1997
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	LMB — Device, Digital Image Storage, Radiological
Device Class	Class I — General Controls
CFR Regulation	21 CFR 892.2010
Definition	Medical Image Storage Hardware Is A Device That Provides Electronic Maintenance And Access Functions For Medical Images.