Cleared Traditional

K880200 - EXL-14 MEDICAL LINEAR ACCELERATOR

K880200 is an FDA 510(k) clearance for EXL-14 MEDICAL LINEAR ACCELERATOR, manufactured by Mitsubishi Intl. Corp.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K880200 · Mitsubishi Intl. Corp. · Radiology device
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Aug 1988
Decision
206d
Days
Class 2
Risk

K880200 is an FDA 510(k) clearance for the EXL-14 MEDICAL LINEAR ACCELERATOR. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Mitsubishi Intl. Corp. (Philadelphia, US). The FDA issued a Cleared decision on August 4, 1988 after a review of 206 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mitsubishi Intl. Corp. devices

FDA 510(k) Submission Details - K880200

510(k) Number K880200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1988
Decision Date August 04, 1988
Days to Decision 206 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 107d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

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 442
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K880200.
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