Cleared Traditional

K770693 - X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC

K770693 is an FDA 510(k) clearance for X-RAY DEVICE, manufactured by Xonics Medical Systems, Inc.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 112-day FDA review.

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

FDA 510(k) Submission Details - K770693

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.

IZH Device Classification - Class 2, Special Controls

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.