Cleared Traditional

K974118 - WORLDWIDE MEDICAL TECHNOLOGIES SEED IMP...

K974118 is an FDA 510(k) clearance for WORLDWIDE MEDICAL TECHNOLOGIES SEED IMP..., manufactured by Worldwide Medical Technologies, LLC. The device is a Class 1 Radiology device with product code IWJ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K974118 · Worldwide Medical Technologies, LLC · Radiology device
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Jan 1998
Decision
84d
Days
Class 1
Risk

K974118 is an FDA 510(k) clearance for the WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET. Classified as System, Applicator, Radionuclide, Manual (product code IWJ), Class I - General Controls.

Submitted by Worldwide Medical Technologies, LLC (Woodbury, US). The FDA issued a Cleared decision on January 23, 1998 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5650 - 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 Worldwide Medical Technologies, LLC devices

FDA 510(k) Submission Details - K974118

510(k) Number K974118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1997
Decision Date January 23, 1998
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

IWJ Device Classification - Class 1, General Controls

Product Code IWJ System, Applicator, Radionuclide, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.5650
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 - IWJ System, Applicator, Radionuclide, Manual

All 15
Devices cleared under the same product code (IWJ) and FDA review panel - the closest regulatory comparables to K974118.
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