Cleared Traditional

OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE

K973463 · O Tech, Inc. · Radiology

Dec 1997

Decision

81d

Days

Class 1

Risk

About This 510(k) Submission

K973463 is an FDA 510(k) clearance for the OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE, 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 December 2, 1997, 81 days after receiving the submission on September 12, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2010.

Submission Details

510(k) Number	K973463 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 12, 1997
Decision Date	December 02, 1997
Days to Decision	81 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.