Cleared Traditional

K093714 - SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM

K093714 is an FDA 510(k) clearance for SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM, manufactured by Medison Co., Ltd.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K093714 · Medison Co., Ltd. · Radiology device
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Optimized for regulatory review, auditing and printing
Dec 2009
Decision
8d
Days
Class 2
Risk

K093714 is an FDA 510(k) clearance for the SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Medison Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on December 10, 2009 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 Medison Co., Ltd. devices

FDA 510(k) Submission Details - K093714

510(k) Number K093714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2009
Decision Date December 10, 2009
Days to Decision 8 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
99d faster than avg
Panel avg: 107d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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

Regulatory Technology Services, LLC
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 - ITX Transducer, Ultrasonic, Diagnostic

All 223
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