Cleared Traditional

K020353 - OMNIA X/XS ULTRASOUND SYSTEM

K020353 is an FDA 510(k) clearance for OMNIA X/XS ULTRASOUND SYSTEM, manufactured by Siemens Medical Systems, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K020353 · Siemens Medical Systems, Inc. · Radiology device
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Feb 2002
Decision
9d
Days
Class 2
Risk

K020353 is an FDA 510(k) clearance for the OMNIA X/XS ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Siemens Medical Systems, Inc. (Issaquah, US). The FDA issued a Cleared decision on February 13, 2002 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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 Siemens Medical Systems, Inc. devices

FDA 510(k) Submission Details - K020353

510(k) Number K020353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2002
Decision Date February 13, 2002
Days to Decision 9 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 107d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IYN Device Classification - Class 2, Special Controls

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 Consultant

Tuv Product Service, Inc.
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

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