Cleared Traditional

K262093 - Accuro XV

K262093 is an FDA 510(k) clearance for Accuro XV, manufactured by Rivanna Medical, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K262093 · Rivanna Medical, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
120d
Days
Class 2
Risk

K262093 is an FDA 510(k) clearance for the Accuro XV. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Rivanna Medical, Inc. (Charlottesville, US). The FDA issued a Cleared decision on October 20, 2026 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K262093

510(k) Number K262093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2026
Decision Date October 20, 2026
Days to Decision 120 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 107d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 882
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K262093.
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K262093 · Accuro XV
Download PDF FDA Summary Rivanna Medical, Inc.