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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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Clever One is a dental imaging software designed to acquire, process, view, edit, and analyze medical images for supporting diagnostic and preoperative planning purposes. It supports standard DICOM formats for 2D and 3D image files and enables advanced imaging functionalities for enhanced diagnostic accuracy. The software provides a range of features, including: - 2D Imaging: Loading, editing, and viewing 2D dental images in standard formats (e.g., DICOM, JPG, BMP). - 3D Imaging: Visualization and reconstruction of 3D CT images, including multi-planar views (MPR) and volume rendering. - Preoperative Planning: Implant position simulation, canal drawing, and bone density analysis to support treatment planning. - Data Interoperability: Facilitates data transfer and storage using DICOM-compliant workflows, ensuring compatibility with third-party systems and imaging devices. The software interfaces with dental imaging equipment, such as CT, panoramic, cephalometric, and intraoral X-ray systems, as well as intraoral cameras, for image acquisition. It is designed for use in network environments, allowing users to upload and download clinical diagnostic images and patient data for enhanced collaboration and efficient patient management.
EWOO SOFT Co., Ltd
1.0
In Commercial Distribution

  • 08800019700593 ()


  • General-purpose dental x-ray system application software
GGI Genius (TM) System 200
Covidien LP
GGS200
In Commercial Distribution

  • 10884521844544 ()

  • Power Supply,100-240,VAC;Frequency,50-60,Hertz;Power,240,W;


  • Endoscopic video image interpretive unit
GGI Genius (TM) System 100
Covidien LP
GGS100
In Commercial Distribution

  • 10884521844537 ()

  • Power Supply,100-240,VAC;Frequency,50-60,Hertz;Power,240,W;


  • Endoscopic video image interpretive unit
Intelligent Endoscopy Module , Refurbished
Covidien LP
CB1708-RFB
In Commercial Distribution

  • 10884521821545 ()


  • Endoscopic video image interpretive unit
ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. ClariSIGMAM calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. ClariSIGMAM provides these numerical values along with breast density category in BI-RADS 5th Edition to aid radiologists in the assessment of breast tissue composition. ClariSIGMAM produces adjunctive information. It is not an interpretive or diagnostic aid.
ClariPI Inc.
1.1.7
In Commercial Distribution

  • 08800046800013 ()


  • Radiology DICOM image processing application software
Burn Navigator RX
ARCOS, INC.
RX
In Commercial Distribution

  • B2551143 ()
1143

  • Clinical information system web-based application software
Burn Navigator H2 Transport
ARCOS, INC.
H2 Transport
In Commercial Distribution

  • B2551125 ()
1125

  • Clinical information system web-based application software
Burn Navigator H2 model
ARCOS, INC.
H2
In Commercial Distribution

  • B2551120 ()
1120

  • Clinical information system web-based application software
No Description
STRYKER CORPORATION
3105001000
In Commercial Distribution

  • 07613327382570 ()
3105001000

  • Radiology DICOM image processing application software
The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AF detection function is not recommended for users with other known arrhythmias. The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG Spot Check is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old
FITBIT, INC.
FB603
In Commercial Distribution

  • 00810038851983 ()


  • Cardiopulmonary physiological parameter analysis software
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