Cleared Traditional

K924164 - DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT
(FDA 510(k) Clearance)

K924164 · Eigen · Radiology

Nov 1992

Decision

96d

Days

Class 2

Risk

K924164 is an FDA 510(k) clearance for the DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT. This device is classified as a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA).

Submitted by Eigen (Nevada City, US). The FDA issued a Cleared decision on November 23, 1992, 96 days after receiving the submission on August 19, 1992.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K924164 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 1992
Decision Date	November 23, 1992
Days to Decision	96 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF