Cleared Traditional

K942243 - IMEX 8000 PERSONAL CASCULAR LAB
(FDA 510(k) Clearance)

K942243 · Imex Medical Systems, Inc. · Radiology

Nov 1995

Decision

543d

Days

Class 2

Risk

K942243 is an FDA 510(k) clearance for the IMEX 8000 PERSONAL CASCULAR LAB. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO).

Submitted by Imex Medical Systems, Inc. (Golden, US). The FDA issued a Cleared decision on November 3, 1995, 543 days after receiving the submission on May 9, 1994.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number	K942243 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 09, 1994
Decision Date	November 03, 1995
Days to Decision	543 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF