Cleared Traditional

K801675 - U.I. OCTOSON

K801675 is an FDA 510(k) clearance for U.I. OCTOSON, manufactured by Ausonics Pty , Ltd.. The device is a Class 2 Radiology device with product code LEJ cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K801675 · Ausonics Pty , Ltd. · Radiology device
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Oct 1980
Decision
93d
Days
Class 2
Risk

K801675 is an FDA 510(k) clearance for the U.I. OCTOSON. Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Ausonics Pty , Ltd. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 878.4635 - 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 Ausonics Pty , Ltd. devices

FDA 510(k) Submission Details - K801675

510(k) Number K801675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1980
Decision Date October 23, 1980
Days to Decision 93 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 107d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LEJ Device Classification - Class 2, Special Controls

Product Code LEJ Booth, Sun Tan
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4635
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 - LEJ Booth, Sun Tan

All 12
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