Cleared Traditional

DIGITAL VIDEO RECORDING SYSTEM

K991738 · Kay Elemetrics Corp. · Radiology
Aug 1999
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K991738 is an FDA 510(k) clearance for the DIGITAL VIDEO RECORDING SYSTEM, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Kay Elemetrics Corp. (Lincoln Park, US). The FDA issued a Cleared decision on August 13, 1999, 84 days after receiving the submission on May 21, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K991738 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 1999
Decision Date August 13, 1999
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