Cleared Traditional

POLYDOROS SX 65 AND 80

K950883 · Siemens Medical Solutions USA, Inc. · Radiology
Apr 1995
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K950883 is an FDA 510(k) clearance for the POLYDOROS SX 65 AND 80, a Generator, High-voltage, X-ray, Diagnostic (Class I — General Controls, product code IZO), submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on April 3, 1995, 34 days after receiving the submission on February 28, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1700.

Submission Details

510(k) Number K950883 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 1995
Decision Date April 03, 1995
Days to Decision 34 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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