Cleared Traditional

K020068 - SONOREAL 3D SYSTEM

K020068 is an FDA 510(k) clearance for SONOREAL 3D SYSTEM, manufactured by Bio Medi Com. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K020068 · Bio Medi Com · Radiology device
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Mar 2002
Decision
54d
Days
Class 2
Risk

K020068 is an FDA 510(k) clearance for the SONOREAL 3D SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Bio Medi Com (Indianpolis, US). The FDA issued a Cleared decision on March 4, 2002 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bio Medi Com devices

FDA 510(k) Submission Details - K020068

510(k) Number K020068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2002
Decision Date March 04, 2002
Days to Decision 54 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 107d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

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