Cleared Traditional

SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G

K952822 · Shimadzu Corp. · Radiology
Jul 1995
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K952822 is an FDA 510(k) clearance for the SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G, a Generator, High-voltage, X-ray, Diagnostic (Class I — General Controls, product code IZO), submitted by Shimadzu Corp. (Kyoto City 604 Japan, JP). The FDA issued a Cleared decision on July 12, 1995, 22 days after receiving the submission on June 20, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1700.

Submission Details

510(k) Number K952822 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1995
Decision Date July 12, 1995
Days to Decision 22 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

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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