Cleared Traditional

K110920 - UF-760AG

K110920 is an FDA 510(k) clearance for UF-760AG, manufactured by Fukuda Denshi Co., Ltd.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K110920 · Fukuda Denshi Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
7d
Days
Class 2
Risk

K110920 is an FDA 510(k) clearance for the UF-760AG. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Fukuda Denshi Co., Ltd. (Redmond, US). The FDA issued a Cleared decision on April 8, 2011 after a review of 7 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.

FDA 510(k) Submission Details - K110920

510(k) Number K110920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2011
Decision Date April 08, 2011
Days to Decision 7 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
100d faster than avg
Panel avg: 107d · This submission: 7d
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 408
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K110920.
KONIX ULTRASOUND GEL
K101952 · Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa · May 2011
CUBESCAN / BIOCON-700
K111021 · Mcube Technology Co., Ltd. · Apr 2011
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K110999 · Edan Instruments, Inc. · Apr 2011
FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB
K110202 · Fujifilm Medical System U.S.A., Inc. · Feb 2011
PET-512MC TRANSESOPHAGEAL TRANSDUCER
K103629 · Toshiba America Medical Systems, In.C · Feb 2011
TERASON T3200 ULTRASOUND SYSTEM
K110020 · Teratech Corp. · Jan 2011
K110920 · UF-760AG
Download PDF FDA Summary Fukuda Denshi Co., Lt…