Technology | Orthopedic Imaging | March 24, 2016

Carestream Submits FDA Clearance Application for OnSight 3-D Extremity System

Cone beam CT system designed to capture high-quality 3-D diagnostic images of extremities

Carestream, FDA application, OnSight 3-D Extremity CBCT System, cone beam computed tomography

March 24, 2016 — Carestream Health has filed a 510(k) application with the U.S. Food and Drug Administration (FDA) for clearance of its OnSight 3-D Extremity System. The system uses cone beam computed tomography (CBCT) technology to capture weight-bearing and other types of patient extremity images. It is designed to offer high-quality, low-dose 3-D imaging for use by orthopedic and sports medicine practices, hospitals, imaging centers, urgent care facilities and other healthcare providers.

The company is currently conducting trials and research studies of the CBCT system in the United States and Europe. UBMD Orthopedics & Sports Medicine (Buffalo, N.Y.), Erie County Medical Center (Buffalo, N.Y.) and Carestream are conducting an institutional IRB-approved clinical study designed to help orthopedic surgeons more accurately and objectively diagnose the degree of instability of the patella (knee cap).

“We compare images obtained on a conventional CT scanner to those obtained on the prototype CBCT scanner while the patient is standing, the quadriceps is active and the knee is flexed to 30 degrees,” said John Marzo, M.D., a physician with UBMD Orthopedics & Sports Medicine, associate professor of clinical orthopedics, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo and former medical director, Buffalo Bills.

“The orthopedic specialists involved in the clinical study are extremely satisfied with image quality from the CBCT scanner and have provided positive feedback on the benefits provided by the use of this technology for weight-bearing exams,” he added.

HUS Medical Imaging Center (Helsinki, Finland) is the site of the first European clinical study of Carestream’s 3-D extremity system in pre- and post-operative cases. During the six-month project, experienced radiologists will evaluate the system’s image quality in bone structure, fractures and the level of metal artifacts. 

Radiologists, technologists and other team members at Erie County Medical Center (ECMC) have provided valuable feedback on the system’s design and performance during research studies and trials conducted at their facility. Medical staff from Great Lakes Medical Imaging — a leading radiology group and official imaging service of the Buffalo Bills and the Buffalo Sabres — also have provided support to these patient studies.

For more information: www.carestream.com

Related Content

Siemens Healthineers Demonstrates Artificial Intelligence, Healthcare Digitalization at HIMSS19
News | Artificial Intelligence | February 13, 2019
February 13, 2019 — At the 2019 Healthcare Information and Management Systems Society (HIMSS) global conference and e
Canon Adds Radiation Therapy Package to Aquilion Prime, Lightning CT Systems
News | Computed Tomography (CT) | February 11, 2019
In the patient-centric world of radiation oncology, it is critical that computed tomography (CT) simulation is...
Korean National Training Center Installs Carestream OnSight 3D Extremity System
News | Computed Tomography (CT) | February 07, 2019
Jincheon National Training Center in Jincheon, South Korea, installed a Carestream OnSight 3D Extremity System at its...
Canon Medical Debuts Alphenix 4-D CT at RSNA 2018
Technology | Angiography | February 06, 2019
Canon Medical Systems USA Inc. recently introduced a new angiography configuration featuring its Alphenix Sky + C-arm...
Konica Minolta Releases Sonimage HS1 Ultrasound Software Upgrade
News | Ultrasound Imaging | January 31, 2019
Konica Minolta Healthcare Americas Inc. released a new software upgrade for the Sonimage HS1 Ultrasound System that...
MaxQ AI's Accipio Software Integrated to GE's Smart Subscription Platform
News | Computed Tomography (CT) | January 29, 2019
MaxQ AI and GE Healthcare announced that MaxQ's Accipio artificial intelligence (AI) platform will now be a part of GE...
Siemens Healthineers Debuts AI-Rad Companion Chest CT
News | Artificial Intelligence | January 25, 2019
Siemens Healthineers presented its first intelligent software assistant for radiology, the AI-Rad Companion Chest CT,...
3-D Reconstruction of Ichthyosaurus Skull

A 3-D reconstruction of the ichthyosaurus skull from a computed tomography (CT) scan. Image courtesy of Nigel Larkin, taken at Royal Veterinary College, London.

News | Computed Tomography (CT) | January 09, 2019
A nearly meter-long skull of a giant fossil marine ichthyosaur found in a farmer's field more than 60 years ago has...
SCCT Releases New Guideline for CT Use During TAVR
News | Computed Tomography (CT) | January 08, 2019
The Society of Cardiovascular Computed Tomography (SCCT) has released a new expert consensus document for computed...
Artificial Intelligence Pinpoints Nine Different Abnormalities in Head Scans

A brain scan (left) showing an intraparenchymal hemorrhage in left frontal region and a scan (right) of a subarachnoid hemorrhage in the left parietal region. Both conditions were accurately detected by the Qure.ai tool. Image courtesy of Nature Medicine.

News | Artificial Intelligence | January 07, 2019
The rise in the use of computed tomography (CT) scans in U.S. emergency rooms has been a well-documented trend1 in...