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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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LARGE PLATE/WIRE CUTTER HEAVY DUTY CUTS UP TO 3.5 MILLIMETERS MAXIMUM 9.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1103-104XQ
In Commercial Distribution

  • 00192896106772 ()

  • Length: 9.5 Inch


  • Orthopaedic implantable-device cutter
ClariCT.AI, is a software device intended for networking, communication, processing and enhancement of CT images in DICOM format regardless of the manufacturer of CT scanner or model. The original cleared device (K183460) is a software application to denoise on CT images, integrated with the clinical environment through DICOM communication on an on-premise environment, and runs under Microsoft Windows platform. The device consists of Denoise Processing module that denoises CT images and other modules (Window application module) that provide many features such as handling DICOM connection from/to PACS, user interface, worklist management and viewer. The subject device, ClariCT.AI, added a new module (named AI Marketplace Integration module) to the original cleared device (K183460) to enable installation on the AI Marketplace system. The module integrates the Denoising Processor of original device into the AI Marketplace system. ClariCT.AI, consists only of the AI Marketplace Integration Module and the Denoising Processor, can be installed in the AI Marketplace system that integrates centrally with PACS and seamlessly integrates into the existing IT and modality infrastructure. An AI Marketplace system, which can be integrated with the ClariCT.AI, is a cloud-based AI platform service that connects end users (e.g. hospitals, imaging centers) and AI medical imaging applications developed by third parties. These AI Marketplace systems provide many features such as handling DICOM connection from/to PACS, user interface, authentication, worklist control, and orchestrating third party AI applications. With the newly added module, ClariCT.AI will function as a software device integrated with such system, and therefore the responsibility of our software is bound to change so as to take care of only essential functionality such as denoising process and system interface.
ClariPI Inc.
1.3.3
In Commercial Distribution

  • 08800046800136 ()


  • Radiology DICOM image processing application software
Laryngoscopy Forceps Conical Tube 2 Millimeters Shaft 2.5 Millimeters Cup Angled Up 45 Degrees Right Quantum
SONTEC INSTRUMENTS, INC.
1301-280Q
In Commercial Distribution

  • 00192896107731 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable
Laryngoscopy Forceps Conical Tube 1 Millimeter Shaft 1 Millimeter Cup Angled Up 45 Degrees Left Quantum
SONTEC INSTRUMENTS, INC.
1301-232Q
In Commercial Distribution

  • 00192896107694 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable
Laryngoscopy Forceps Conical Tube 2 Millimeters Shaft 2.5 Millimeters Cup Angled Up 45 Degrees Left Quantum
SONTEC INSTRUMENTS, INC.
1301-282Q
In Commercial Distribution

  • 00192896107373 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable
Laryngoscopy Forceps Conical Tube 1 Millimeter Shaft 1 Millimeter Cup Angled Up 45 Degrees Right Quantum
SONTEC INSTRUMENTS, INC.
1301-230Q
In Commercial Distribution

  • 00192896107335 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable
LARYNGOSCOPY FORCEPS CONICAL TUBE 2 MILLIMETERS SHAFT 2.5 X 4 MILLIMETERS CUP POINTED UP-ANGLE RIGHT QUANTUM
SONTEC INSTRUMENTS, INC.
1301-294Q
In Commercial Distribution

  • 00192896107052 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable
LARYNGOSCOPY FORCEPS CONICAL TUBE 2 MILLIMETERS SHAFT 2.5 X 4 MILLIMETERS CUP POINTED UP-ANGLE LEFT QUANTUM
SONTEC INSTRUMENTS, INC.
1301-296Q
In Commercial Distribution

  • 00192896107038 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable
WIRE END CUTTER DOUBLE ACTION TUNGSTEN CARBIDE CUTS WIRE UP TO 2.5 MILLIMETERS 8.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1103-100Q
In Commercial Distribution

  • 00192896082571 ()

  • Cuts Wire up to 2.5 Millimeter
  • Length: 8.5 Inch
1103-100Q

  • Orthopaedic implantable-device cutter
A Bluetooth blood pressure monitor compatible with the DaliaHealth platform, measuring heart rate, diastolic and systolic blood pressure, and an AI analysis for irregular heartbeats.
Stethoai LLC
1
In Commercial Distribution

  • 00860011532828 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
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