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510(k) Data Aggregation
K Number
K131873Device Name
NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)
Manufacturer
Date Cleared
2013-09-25
(93 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
METHODSENSE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NDOHD system is intended for viewing, acquiring, archiving and retrieving video and still images of endoscopic and fluoroscopic procedures. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device. The NDOHD system is not intended to be used in an environment that requires sterilization.
Device Description
The NDOHD High Definition Imaging System (NDOHD) was initially commercialized in 2011 as a photographic accessory for endoscopes (FEM), Class I Exempt device. Altaravision has expanded the capabilities of the NDOHD system to include a computer and a camera, included a lossy image compression mechanism using standard irreversible compression technique, H.264, added a time code on the display of the image, created camera controls and added profiles for multiple camera settings and user preferences. Therefore, Altaravision has created a picture archiving and communication system that provides capabilities related to the acceptance, transfer, display, storage and digital processing of images and videos.
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