Cleared Traditional

K931930 - POYDOROS LX

K931930 is an FDA 510(k) clearance for POYDOROS LX, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K931930 · Siemens Medical Solutions USA, Inc. · Radiology device
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Sep 1993
Decision
144d
Days
Class 1
Risk

K931930 is an FDA 510(k) clearance for the POYDOROS LX. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on September 7, 1993 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1700 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K931930

510(k) Number K931930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1993
Decision Date September 07, 1993
Days to Decision 144 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 107d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

IZO Device Classification - Class 1, General Controls

Product Code IZO Generator, High-voltage, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1700
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IZO Generator, High-voltage, X-ray, Diagnostic

All 99
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K931930.
RADIOGRAPHIC GENERATOR HFQ-WHIS
K935068 · Bennett X-Ray Corp. · Dec 1993
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G
K933471 · Shimadzu Corp. · Nov 1993
PHILIPS XRG 90 X-RAY GENERATOR SYSTEM
K933650 · Philips Medical Systems North America, Inc. · Oct 1993
POLYDOROS IS
K933240 · Siemens Medical Solutions USA, Inc. · Sep 1993
LCR GENERATOR
K931998 · Philips Medical Systems (Cleveland), Inc. · Jul 1993
RSX 30HF
K930792 · Fischer Imaging Corp. · May 1993