Cleared Traditional

K872357 - TRANSWORLD 360V, MODEL A1-4040

K872357 is an FDA 510(k) clearance for TRANSWORLD 360V, manufactured by Transworld X-Ray Corp.. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K872357 · Transworld X-Ray Corp. · Radiology device
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Jul 1987
Decision
27d
Days
Class 1
Risk

K872357 is an FDA 510(k) clearance for the TRANSWORLD 360V, MODEL A1-4040. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Transworld X-Ray Corp. (Charlotte, US). The FDA issued a Cleared decision on July 15, 1987 after a review of 27 days - a notably fast clearance cycle.

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: 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 Transworld X-Ray Corp. devices

FDA 510(k) Submission Details - K872357

510(k) Number K872357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1987
Decision Date July 15, 1987
Days to Decision 27 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 107d · This submission: 27d
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 100
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