Cleared Traditional

K935123 - SUPERSTAND 300

K935123 is an FDA 510(k) clearance for SUPERSTAND 300, manufactured by Wuestec Medical, Inc.. The device is a Class 1 Radiology device with product code IYB cleared through the Traditional 510(k) pathway after a 881-day FDA review.

K935123 · Wuestec Medical, Inc. · Radiology device
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Mar 1996
Decision
881d
Days
Class 1
Risk

K935123 is an FDA 510(k) clearance for the SUPERSTAND 300. Classified as Tube Mount, X-ray, Diagnostic (product code IYB), Class I - General Controls.

Submitted by Wuestec Medical, Inc. (Mobile, US). The FDA issued a Cleared decision on March 27, 1996 after a review of 881 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1770 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

FDA 510(k) Submission Details - K935123

510(k) Number K935123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1993
Decision Date March 27, 1996
Days to Decision 881 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
774d slower than avg
Panel avg: 107d · This submission: 881d
Pathway characteristics
Predicate-based equivalence.

IYB Device Classification - Class 1, General Controls

Product Code IYB Tube Mount, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1770
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 - IYB Tube Mount, X-ray, Diagnostic

All 29
Devices cleared under the same product code (IYB) and FDA review panel - the closest regulatory comparables to K935123.
MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000
K946261 · Scott Imaging Intl., Inc. · Feb 1995
CTS SYSTEM
K941004 · Acoma Medical Imaging, Inc. · Jul 1994
F/C/W TUBESTAND
K941017 · Acoma Medical Imaging, Inc. · Jul 1994
MPR-814
K940442 · Xri, Inc. · Jun 1994
MODEL ALPHA TS-2
K935004 · Dpa Consulting, Inc. · Dec 1993
SUPERSTAND 3000
K933253 · Wuestec Medical, Inc. · Aug 1993
K935123 · SUPERSTAND 300
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