TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LABORPRO SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

3DI

FDA 510(k)

FDA Class 2 ·Radiology

CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX

FDA 510(k)

FDA Class 2 ·Cardiovascular

CarboClear® Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

AcuPulse CO2 Laser System, Delivery Devices and Accessories

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

xvision Spine System

FDA 510(k)

FDA Class 2 ·Neurology

MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

UltraSight AI Guidance

FDA 510(k)

FDA Class 2 ·Radiology

SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option

FDA 510(k)

FDA Class 2 ·Radiology

HOLOSCOPE-i

FDA 510(k)

FDA Class 2 ·Radiology

HORIZON XVU (FFR)

FDA 510(k)

FDA Class 2 ·Cardiovascular

BrainsWay Deep TMS System

FDA 510(k)

FDA Class 2 ·Neurology

Noris Medical MBI-2mm Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

MODIFICATION TO ENDOFAST RELIANT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS

FDA 510(k)

FDA Class 2 ·Radiology

Brainsway Deep TMS System

FDA 510(k)

FDA Class 2 ·Neurology

BriefCase-Triage

FDA 510(k)

FDA Class 2 ·Radiology

Capnostream 35 Portable Respiratory Monitor

FDA 510(k)

FDA Class 2 ·Anesthesiology

Pure Vu

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology