Cleared Traditional

K760741 - PORTABLE X-RAY (FDA 510(k) Clearance)

Oct 1976
Decision
5d
Days
Class 2
Risk

K760741 is an FDA 510(k) clearance for the PORTABLE X-RAY. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).

Submitted by Minxray, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 5, 1976, 5 days after receiving the submission on September 30, 1976.

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

Submission Details

510(k) Number K760741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1976
Decision Date October 05, 1976
Days to Decision 5 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -

Device Classification

Product Code IZL - System, X-ray, Mobile
Device Class Class II - Special Controls
CFR Regulation 21 CFR 892.1720

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