Cleared Special

K081919 - UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM

K081919 is an FDA 510(k) clearance for UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM, manufactured by Fukuda Denshi Co., Ltd.. The device is a Class 2 Radiology device with product code ITX cleared through the Special 510(k) pathway after a 64-day FDA review.

K081919 · Fukuda Denshi Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
64d
Days
Class 2
Risk

K081919 is an FDA 510(k) clearance for the UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM. 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 September 9, 2008 after a review of 64 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K081919

510(k) Number K081919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2008
Decision Date September 09, 2008
Days to Decision 64 days
Submission Type Special
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
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Modification to existing cleared device. 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

Citech
ROBERT MOSENKIS

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 K081919.
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K081919 · UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM
Download PDF FDA Summary Fukuda Denshi Co., Lt…