Cleared Traditional

K771817 - EMI THERAPY SIMULATOR

K771817 is an FDA 510(k) clearance for EMI THERAPY SIMULATOR, manufactured by Emi Therapy Systems, Inc.. The device is a Class 2 Radiology device with product code JAD cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K771817 · Emi Therapy Systems, Inc. · Radiology device
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Jan 1978
Decision
109d
Days
Class 2
Risk

K771817 is an FDA 510(k) clearance for the EMI THERAPY SIMULATOR. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Emi Therapy Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 13, 1978 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - 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 Emi Therapy Systems, Inc. devices

FDA 510(k) Submission Details - K771817

510(k) Number K771817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1977
Decision Date January 13, 1978
Days to Decision 109 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 107d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAD Device Classification - Class 2, Special Controls

Product Code JAD System, Therapeutic, X-ray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5900
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.