Cleared Traditional

K080970 - USHIFU STEPPER

K080970 is an FDA 510(k) clearance for USHIFU STEPPER, manufactured by Ushifu Development Company, LLC. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K080970 · Ushifu Development Company, LLC · Radiology device
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Jun 2008
Decision
68d
Days
Class 2
Risk

K080970 is an FDA 510(k) clearance for the USHIFU STEPPER. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Ushifu Development Company, LLC (Deland, US). The FDA issued a Cleared decision on June 11, 2008 after a review of 68 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 Ushifu Development Company, LLC devices

FDA 510(k) Submission Details - K080970

510(k) Number K080970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2008
Decision Date June 11, 2008
Days to Decision 68 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
39d faster than avg
Panel avg: 107d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - ITX Transducer, Ultrasonic, Diagnostic

All 287
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