Cleared Traditional

K780027 - ACCELERATOR, LINEAR, MED.

K780027 is an FDA 510(k) clearance for ACCELERATOR, manufactured by Emi Therapy Systems, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K780027 · Emi Therapy Systems, Inc. · Radiology device
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Jan 1978
Decision
22d
Days
Class 2
Risk

K780027 is an FDA 510(k) clearance for the ACCELERATOR, LINEAR, MED.. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Emi Therapy Systems, Inc. (Walker, US). The FDA issued a Cleared decision on January 26, 1978 after a review of 22 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 Emi Therapy Systems, Inc. devices

FDA 510(k) Submission Details - K780027

510(k) Number K780027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1978
Decision Date January 26, 1978
Days to Decision 22 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 107d · This submission: 22d
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 617
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K780027.
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