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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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Icad, Inc.
V9
Not in Commercial Distribution

  • 00858012005946 ()


  • Radiology DICOM image processing application software
MRS calculator
Aclarion, Inc.
Nocicalc
In Commercial Distribution

  • 00860010437209 ()
200-00301

  • Radiology DICOM image processing application software
The Heidelberg pH capsule system software package intended to add image processing and/or analysis capabilities to a gastric and gastrointestinal telemetric monitoring system used to help diagnose gastric pH disorders and/or measure gastric and gastrointestinal pH via wirelessly transmitted signals from a pH telemetric capsule swallowed by the patient. It may be installed in a portable hand-held receiver or in a computing device to which measured data that is transmitted by a transceiver.
Heidelberg Medical Inc
Heidelberg pH Capsule System Software
In Commercial Distribution

  • B989HCNS180 ()
HCNS18

  • Gastrointestinal telemetric monitoring system application software
STROBE CASE F/FLEX SCOPE & HIGH LT
JEDMED INSTRUMENT COMPANY
49-4991
In Commercial Distribution

  • M6334949910 ()
49-4991

  • Laryngostroboscope system
INTEGRATION BROKER ANNUAL SUPPORT DICO
Smith & Nephew, Inc.
72201082
In Commercial Distribution

  • 03596010588388 ()
72201082

  • Robotic surgical navigation system application software
Prism Flow® is the DICOM communications and storage and Prism workflow manager. It provides integrated access, application configuration, and audit logging across physical locations and the cloud. The dedicated DICOM store holds raw, intermediate and processed results, as well as providing DICOM interoperability with scanners, PACS, treatment planning, and surgical navigation systems through powerful configurable sender/receiver and forwarding functions.
PRISM CLINICAL IMAGING, INC.
4.1
In Commercial Distribution

  • B358PCI01PF0 ()
PCI01PF

  • Radiology DICOM image processing application software
Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is a zero-footprint, web-based software device indicated for use in clinical settings where medical images and image-derived metadata can be accessed or visualized to aid healthcare professionals in diagnosis and patient management decision making. Eureka AI Results Explorer’s web interfaces can obtain and consume both DICOM and non-DICOM image-derived metadata generated by Artificial Intelligence (AI) or computer vision algorithms.
Terarecon Inc.
Eureka AI Results Explorer
In Commercial Distribution

  • B2208430011 ()


  • Radiology DICOM image processing application software
KARL STORZ PULSAR II Stroboscope
Karl Storz GmbH & Co. KG
40160120
In Commercial Distribution

  • 04048551242513 ()


  • Laryngostroboscope system
BULB, HALOGEN
PENTAX OF AMERICA, INC.
2140-0031
In Commercial Distribution

  • 04961333241903 ()


  • Laryngostroboscope system
Software calculator for magnetic resonance spectroscopy (MRS) used by the Nociscan-LS exam for Lumbar disc pain
Aclarion, Inc.
NociCalc
Not in Commercial Distribution

  • 00196852733996 ()


  • Radiology DICOM image processing application software
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