Cleared Traditional

K833226 - PMX MOBILE X-RAY SYSTEM (FDA 510(k) Clearance)

K833226 · Philips Medical Systems, Inc. · Radiology device

Oct 1983

Decision

71d

Days

Class 2

Risk

K833226 is an FDA 510(k) clearance for the PMX MOBILE X-RAY SYSTEM. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).

Submitted by Philips Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 28, 1983, 71 days after receiving the submission on August 18, 1983.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number	K833226 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 18, 1983
Decision Date	October 28, 1983
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—