Cleared Traditional

K233977 - Velacur

K233977 is an FDA 510(k) clearance for Velacur, manufactured by Sonic Incytes. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K233977 · Sonic Incytes · Radiology device
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Optimized for regulatory review, auditing and printing
Sep 2024
Decision
261d
Days
Class 2
Risk

K233977 is an FDA 510(k) clearance for the Velacur. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Sonic Incytes (Vancouver, CA). The FDA issued a Cleared decision on September 4, 2024 after a review of 261 days - an extended review cycle.

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.

View all Sonic Incytes devices

FDA 510(k) Submission Details - K233977

510(k) Number K233977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2023
Decision Date September 04, 2024
Days to Decision 261 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
154d slower than avg
Panel avg: 107d · This submission: 261d
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 Consultant

Z&B Enterprises, Inc.
Rhona Shanker

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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 448
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