K241029

SpineUs™ System

510(k) number
K241029
Device name
SpineUs™ System
Applicant
Verdure Imaging CA · US
Product code
IYO — System, Imaging, Pulsed Echo, Ultrasonic
Decision date
2024-10-07
Date received
2024-04-15
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
510(k) Summary (official FDA PDF): K241029.pdf
Official FDA record: K241029
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.