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Virtual Nodule Clinic (VNC) is a software application designed for trained medical professionals in the clinical management of patients with incidentally detected pulmonary nodules. The software assists the user with (1) management and tracking of patients with indeterminate pulmonary nodules (IPNs), available to all users and (2) a computer-aided diagnosis (CADx) function that takes a user-selected ROI and uses artificial intelligence to synthesize its morphological characteristics into a single value, the Optellum Lung Cancer Predictor (LCP) Score, only available to radiologists and pulmonologists.
OPTELLUM LTD
2.3
In Commercial Distribution
- B816VNC2P30 ()
N/A
- CT system application software
Virtual Nodule Clinic (VNC) is a software application designed for trained medical professionals in the clinical management of patients with incidentally detected pulmonary nodules. The software assists the user with (1) management and tracking of patients with indeterminate pulmonary nodules (IPNs), available to all users and (2) a computer-aided diagnosis (CADx) function that takes a user-selected ROI and uses artificial intelligence to synthesize its morphological characteristics into a single value, the Optellum Lung Cancer Predictor (LCP) Score, only available to radiologists and pulmonologists.
OPTELLUM LTD
2.1.0
In Commercial Distribution
- B816VNC2P10 ()
N/A
- CT system application software
Mixing Wells, 4-Well, Assorted Colors
PLASDENT CORPORATION
900MW-4(A)
In Commercial Distribution
- D832900MW4A0 ()
- D832900MW4A1 ()
900MW-4(A)
- Dental material mixing surface, chairside, single-use
Mixing Wells, 2-Well, Assorted Colors
PLASDENT CORPORATION
900MW-2(A)
In Commercial Distribution
- D832900MW2A0 ()
- D832900MW2A1 ()
900MW-2(A)
- Dental material mixing surface, chairside, single-use
Tinted Powder
JBC and Company
DPF/A
In Commercial Distribution
- D851DPFA0 ()
DPF/A
- Dental appliance fabrication material, resin
WebPAX® is intended for use in the communication and storage of medical images. WebPAX® is also
intended for use as a comprehensive solution to view, optimize, and post-process diagnostic medical
images as an aid to physicians and other healthcare professionals in the evaluation of digital imaging
examinations.
HEART IMAGING TECHNOLOGIES, LLC
9
In Commercial Distribution
- B127WP90 ()
n/a
- Medical image management system
Decellularized Bovine Pericardium
GENESEE BIOMEDICAL, INC.
PFP6x8
In Commercial Distribution
- B040PFP6X81 ()
N/A
- Cardiovascular patch, animal-derived
The higi Station is intended for use by the general public to measure blood pressure, pulse, body weight, percent body fat, percent lean body mass, total body water and calculate body mass index. It is not a diagnostic device and only furnishes data so that users can consult their personal physician or other healthcare professional. The user can choose to store or send the data to a personal physician or healthcare professional. Users must be 13 years of age to use the higi Station.
HIGI SH LLC
ZT2776A0021
In Commercial Distribution
- B146ZT2776A00210 ()
n/a
- Automatic-inflation electronic sphygmomanometer, non-portable
StimWear™ CONDUCTIVE ARM SLEEVE with 1oz CONDUCTIVE SPRAY
Tensproducts, LLC
STIMKIT-SLEEVE/A
In Commercial Distribution
- B1900580 ()
STIMKIT-SLEEVE/A
- Transcutaneous electrical stimulation electrode, single-use
The CyberKnife® Treatment Delivery System (CKTDS) is a computer-controlled radiation treatment delivery system for performing minimally invasive stereotactic radiosurgery and precision radiotherapy. The CyberKnife Treatment Delivery System is intended to work with Accuray Precision® Treatment Planning System and iDMS™ Data Management System.
Accuray Incorporated
0660000
N/A
- Linear accelerator system