Cleared Traditional

MPH50, MPH65, AND MPH80

K954666 · GE Medical Systems · Radiology
Nov 1995
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K954666 is an FDA 510(k) clearance for the MPH50, MPH65, AND MPH80, a Generator, High-voltage, X-ray, Diagnostic (Class I — General Controls, product code IZO), submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on November 24, 1995, 45 days after receiving the submission on October 10, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1700.

Submission Details

510(k) Number K954666 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 1995
Decision Date November 24, 1995
Days to Decision 45 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IZO — Generator, High-voltage, X-ray, Diagnostic
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.1700

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