Cleared Traditional

K874214 - S9 DISPLAY SYSTEM (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K874214 · O.M.I. Oncology Microsystems, Inc. · Radiology device
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Feb 1988
Decision
129d
Days
Class 2
Risk

K874214 is an FDA 510(k) clearance for the S9 DISPLAY SYSTEM. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by O.M.I. Oncology Microsystems, Inc. (Canada, CA). The FDA issued a Cleared decision on February 22, 1988 after a review of 129 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 O.M.I. Oncology Microsystems, Inc. devices

Submission Details

510(k) Number K874214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1987
Decision Date February 22, 1988
Days to Decision 129 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 107d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.