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SpineUs System

FDA UDI

Class II (US FDA UDI)

by Verdure Imaging

Identity

Trade Name
SpineUs System FDA UDI
Generic Name
Ultrasound imaging system operation software FDA UDI
Device Name
The SpineUs™ System is a diagnostic ultrasound system, which consists of the FDA cleared Clarius Ultrasound Scanner C3 HD3 (K213436), a consumer PC, a tracking system with OptiTrack cameras connected to a POE switch and active LED markers, and the SpineUs™ computer application. The SpineUs™ computer application, installed in the consumer PC, processes the ultrasound imaging data received from the Clarius Ultrasound Scanner and the tracking data received from the tracking system. The SpineUs™ computer application allows the operator to view ultrasound images of the spine, segment the ultrasound images using artificial intelligence, generate and visualize 3D reconstructions of the surface of the spine in real-time, measure spine-related anatomical components (e.g., intervertebral angles and spine curvature), review and manage patient measurement data, and generate and export printable reports. FDA UDI
Model / Reference
000010 FDA UDI
Description
The SpineUs™ System is a diagnostic ultrasound system, which consists of the FDA cleared Clarius Ultrasound Scanner C3 HD3 (K213436), a consumer PC, a tracking system with OptiTrack cameras connected to a POE switch and active LED markers, and the SpineUs™ computer application. The SpineUs™ computer application, installed in the consumer PC, processes the ultrasound imaging data received from the Clarius Ultrasound Scanner and the tracking data received from the tracking system. The SpineUs™ computer application allows the operator to view ultrasound images of the spine, segment the ultrasound images using artificial intelligence, generate and visualize 3D reconstructions of the surface of the spine in real-time, measure spine-related anatomical components (e.g., intervertebral angles and spine curvature), review and manage patient measurement data, and generate and export printable reports. FDA UDI

Identifiers

Primary DI / UDI-DI
G618000010 FDA UDI
510(k) Number
K241029 FDA UDI
FDA Product Code
IYO FDA UDI
ITX FDA UDI
QIH FDA UDI
GMDN Term
Ultrasound imaging system operation software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1560 FDA UDI
892.1570 FDA UDI
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Hand-held ultrasound imaging system, body-surfaceUltrasound imaging system operator consoleUltrasound imaging system operation software

SpineUs System by Verdure Imaging — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasound imaging system operation software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Verdure Imaging

Sources (1)

  • FDA UDI ff8dd363-5797-439a-ae03-e42ae0dc86a0 34 fields · synced May 30, 2026