Cleared Traditional

K982463 - EXTRACRANIAL RADIOTHERAPY SYSTEM

K982463 is the FDA 510(k) clearance for EXTRACRANIAL RADIOTHERAPY SYSTEM by Howmedica, Inc.. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K982463 · Howmedica, Inc. · Radiology device
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Sep 1998
Decision
77d
Days
Class 2
Risk

K982463 is an FDA 510(k) clearance for the EXTRACRANIAL RADIOTHERAPY SYSTEM. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Howmedica, Inc. (Rutherford, US). The FDA issued a Cleared decision on September 30, 1998 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 Howmedica, Inc. devices

Submission Details

510(k) Number K982463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1998
Decision Date September 30, 1998
Days to Decision 77 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
30d faster than avg
Panel avg: 107d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYE Accelerator, Linear, Medical

All 327
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