Cleared Traditional

OPTIVIEW

K972520 · Optimed Technologies, Inc. · Radiology
Sep 1997
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K972520 is an FDA 510(k) clearance for the OPTIVIEW, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Optimed Technologies, Inc. (Livingston, US). The FDA issued a Cleared decision on September 29, 1997, 84 days after receiving the submission on July 7, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K972520 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 1997
Decision Date September 29, 1997
Days to Decision 84 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050