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510(k) Data Aggregation
K Number
K190420Device Name
NDOHD High Definition Imaging System (NDOHD)
Manufacturer
Date Cleared
2019-04-15
(53 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Altaravision Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NDOHD system is intended for viewing, acquiring, recording, 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 NDOнd High Definition Imaging System (NDOнD) previously acquired FDA clearance in 2013 as a Class II picture archiving and communication system that provides capabilities related to the acquisition, transfer, display, storage, and digital processing of images and videos (K131873). Altaravision replaced off the shelf hardware components due to the hardware becoming obsolete. Altaravision also updated the NDOHD software to enable use of the new hardware, improve the software user interface and conform to Apple's latest coding best practices.
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