Cleared Traditional

K923786 - POLYDOROS XS50 AND SX80

K923786 is an FDA 510(k) clearance for POLYDOROS XS50 AND SX80, 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 142-day FDA review.

K923786 · Siemens Medical Solutions USA, Inc. · Radiology device
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Dec 1992
Decision
142d
Days
Class 1
Risk

K923786 is an FDA 510(k) clearance for the POLYDOROS XS50 AND SX80. 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 December 17, 1992 after a review of 142 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 - K923786

510(k) Number K923786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1992
Decision Date December 17, 1992
Days to Decision 142 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
35d slower than avg
Panel avg: 107d · This submission: 142d
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 K923786.
POLYDOROS C
K924078 · Siemens Medical Solutions USA, Inc. · Jan 1993
PHILIPS MEDIO CP FAMILY
K925105 · Philips Medical Systems, Inc. · Dec 1992
PHILIPS SUPER CP FAMILY
K925844 · Philips Medical Systems, Inc. · Dec 1992
X-RAY CONTROL AND HI-VOLTAGE GENERATOR
K921875 · Continental X-Ray Corp. · Oct 1992
MPG 65-80-100 X-RAY GENERATOR AND CONTROL
K921951 · General Electric Co. · Jul 1992
X-RAY HIGH VOLTAGE GENERATOR ED 125L
K920730 · Shimadzu Medical Systems · Apr 1992