Cleared Traditional

K944196 - IMWXDOP IR
(FDA 510(k) Clearance)

K944196 · Imex Medical Systems, Inc. · Radiology
May 1995
Decision
256d
Days
Class 2
Risk

K944196 is an FDA 510(k) clearance for the IMWXDOP IR, a Monitor, Ultrasonic, Nonfetal (Class II — Special Controls, product code JAF), submitted by Imex Medical Systems, Inc. (Golden, US). The FDA issued a Cleared decision on May 12, 1995, 256 days after receiving the submission on August 29, 1994. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1540.

Submission Details

510(k) Number K944196 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 1994
Decision Date May 12, 1995
Days to Decision 256 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAF — Monitor, Ultrasonic, Nonfetal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1540