SpineUs™ System

FDA 510(k) K241029 · Verdure Imaging

Substantially Equivalent

510(k) numberK241029

Submission

Device name
SpineUs™ System
Applicant
Verdure Imaging
Stockton, CA, US
Received
April 15, 2024
Decision date
October 7, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYO – System, Imaging, Pulsed Echo, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1560
Specialty
Radiology

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Questions and answers

When was SpineUs™ System cleared by the FDA?

SpineUs™ System (K241029) received a 510(k) decision of Substantially Equivalent on October 7, 2024, 175 days after the submission was received.

What is the product code of K241029?

The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.