Cleared Traditional

K090465 - DIGDOP ULTRASOUND SYSTEM

K090465 is an FDA 510(k) clearance for DIGDOP ULTRASOUND SYSTEM, manufactured by The Newman Group, LLC. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K090465 · The Newman Group, LLC · Radiology device
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Apr 2009
Decision
44d
Days
Class 2
Risk

K090465 is an FDA 510(k) clearance for the DIGDOP ULTRASOUND SYSTEM. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by The Newman Group, LLC (Lake Bluff, US). The FDA issued a Cleared decision on April 8, 2009 after a review of 44 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 The Newman Group, LLC devices

FDA 510(k) Submission Details - K090465

510(k) Number K090465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2009
Decision Date April 08, 2009
Days to Decision 44 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 107d · This submission: 44d
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 Peers - ITX Transducer, Ultrasonic, Diagnostic

All 284
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K090465.
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