Cleared Traditional

K770693 - X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC (FDA 510(k) Clearance)

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

K770693 · Xonics Medical Systems, Inc. · Radiology device
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Aug 1977
Decision
112d
Days
Class 2
Risk

K770693 is an FDA 510(k) clearance for the X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Xonics Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1977 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - 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 Xonics Medical Systems, Inc. devices

Submission Details

510(k) Number K770693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1977
Decision Date August 03, 1977
Days to Decision 112 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 107d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
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.