Cleared Traditional

K935004 - MODEL ALPHA TS-2

K935004 is an FDA 510(k) clearance for MODEL ALPHA TS-2, manufactured by Dpa Consulting, Inc.. The device is a Class 1 Radiology device with product code IYB cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K935004 · Dpa Consulting, Inc. · Radiology device
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Dec 1993
Decision
55d
Days
Class 1
Risk

K935004 is an FDA 510(k) clearance for the MODEL ALPHA TS-2. Classified as Tube Mount, X-ray, Diagnostic (product code IYB), Class I - General Controls.

Submitted by Dpa Consulting, Inc. (Urbanna, US). The FDA issued a Cleared decision on December 13, 1993 after a review of 55 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dpa Consulting, Inc. devices

FDA 510(k) Submission Details - K935004

510(k) Number K935004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1993
Decision Date December 13, 1993
Days to Decision 55 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 107d · This submission: 55d
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 21
Devices cleared under the same product code (IYB) and FDA review panel - the closest regulatory comparables to K935004.
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