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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Optellum Virtual Nodule Clinic - B816VNC2P30

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

Optellum Virtual Nodule Clinic - B816VNC2P10

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

Radixact™ Treatment Delivery System - M65810602530

Radixact Delivery System Software (Version 1.1)
ACCURAY INCORPORATED
1060253
In Commercial Distribution

  • M65810602530 ()
N/A

  • Linear accelerator system

TomoTherapy® Treatment Delivery System - M65810489680

Software, TomoApps, Version 2.1.1, Build # 5.1.1 (Operating Software for TomoTherapy systems, including TomoH®, TomoHD®, TomoHDA™ and Onrad™)
ACCURAY INCORPORATED
1048968
In Commercial Distribution

  • M65810489680 ()
N/A

  • Linear accelerator system

JEDMED - M633512384A0

STYLET ONLY F/BRUENING NASAL SNARE
JEDMED INSTRUMENT COMPANY
51-2384 A
In Commercial Distribution

  • M633512384A0 ()
51-2384 A

  • Nasal snare, reusable

JEDMED - M633494313A0

ENT Endoscope 2.7MM 30-Deg 175MM
JEDMED INSTRUMENT COMPANY
49-4313 A
In Commercial Distribution

  • M633494313A0 ()
49-4313 A

  • Rigid optical sinoscope

JEDMED - M633494303A0

ENT Endoscope 4MM 30-Deg 175MM
JEDMED INSTRUMENT COMPANY
49-4303 A
In Commercial Distribution

  • M633494303A0 ()
49-4303 A

  • Rigid optical sinoscope

Medisoft - G407870A0

Treadmill 870 A
MEDISOFT RAM ITALIA SRL
870 A
In Commercial Distribution

  • G407870A0 ()
870 A

  • Cardiopulmonary stress exercise treadmill

UltraVision - B616UVTKL1440

Linear Ultrasonic Transducer
ULTRAVISION CORPORATION
Konica Linear Probe L14-4
In Commercial Distribution

  • B616UVTKL1440 ()
n/a

  • Extracorporeal ultrasound imaging transducer, hand-held

UltraVision - B616UVTKHL1840

Linear Ultrasonic Transducer
ULTRAVISION CORPORATION
Konica Hockey Stick Linear 18-4
In Commercial Distribution

  • B616UVTKHL1840 ()
n/a

  • Extracorporeal ultrasound imaging transducer, hand-held
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