Search Results
Found 3 results
510(k) Data Aggregation
K Number
K132853Device Name
NOVAPACS
Manufacturer
NOVARAD CORP.
Date Cleared
2014-10-30
(413 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NOVARAD CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NovaPACS is intended for the viewing, archiving, analysis, annotation, distribution, editing, fusion, and processing of digital medical images and data acquired from diagnostic imaging devices and all DICOM devices, etc.
NovaPACS is intended for use by trained healthcare professionals, including radiologists, physicians, technologists, clinicians, and nurses. NovaPACS allows the end user to display, manipulate, archive, and evaluate images.
NovaPACS is not intended for diagnostic image review on a mobile platform.
While NovaPACS provides tools to assist the healthcare professional determine diagnostic viability, it is the user's responsibility to ensure quality, display contrast, ambient light confirm image compression ratios are consistent with the generally accepted standards of the clinical application.
Device Description
NovaPACS is a picture archiving and communication system software that retrieves, archives, and displays images and data from all common modalities. NovaPACS uses a variety of workstations, including a Technologist Workstation, Enterprise Radiologist Workstation, Cardio Viewer and Workstation, NovaMG Workstation, and NovaWeb Web Viewer.
The NovaPACS software makes images and data available in digital format from all common modalities. The images are viewed on a computer monitor or portable device. NovaPACS tools/features include the following: window, level, zoom, pan, digital subtraction, ejection, cross localization, note-taking ability, voice dictation, and other similar tools. It includes the capability to measure distance and image intensity values, such as standardized uptake value. NovaPACS displays measurement lines, annotations, regions of interest, and fusion blending control functionality. Advanced features include 3D image rendering, virtual colonoscopy, and vessel analysis.
Images and data are stored on a digital archive with multiple redundancies; images and data are site and off-site. Novarad provides all software, including third party software (i.e. Windows® OS). NovaPACS software resides on third party hardware, which may vary depending on the client's PACS needs. All hardware is connected to the radiology department local area network.
NovaPACS integrates with NovaRIS and may integrate with any other third party RIS software that has HL7 interface capabilities.
NovaPACS integrates with Novarad Mobile Rad application to display data on 3rd party mobile platforms. Mobile Rad is not intended to replace a full diagnostic workstation.
Ask a Question
K Number
K063153Device Name
NOVAPACS
Manufacturer
NOVARAD CORP.
Date Cleared
2006-12-07
(52 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NOVARAD CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The product being submitted is going to be used as a PACS system and provide viewing tools for radiologists, technologists, other physicians, cardiologists, and patients. It will also provide archiving of images and data. The product will be sold to hospitals, imaging centers, and clinics. It is a software product sold with accompanying off-the-shelf hardware, It is substantially equivalent to other products now being sold as PACS. Further it is for using DICOM for presentation of Mammography studies, not for image processing. Will include the standard features for Mammo of window/level/zoom, as well as volumetric measurements and other Mammo tools. Mammo will only be interpreted on 510K approved 5 Mp LCD monitors. The Mammo images will be stored lossless (non-lossy compressed). Digitized conventional screen film mammograms will not be used in soft copy format for primary diagnosis.
Device Description
The PACS product provides a system where images and accompanying data are sent from the modalities to the radiologists and technologists in digital format. The images are then viewed on a computer with such available tools a window, level, zoom, pan, roi, digital subtraction, ejection fraction, cross localize, and many other similar tools and with the ability to make notes and dictate a report. The images and report are then stored long term on a digital archive with multiple redundancy. All the information is also made available as a web based product where referring physicians or radiologists can access the information from anywhere using a secure system. The software is provided by NovaRad along with some 31d party software, principally from windows, and resides on off-the-shelf hardware hooked up to the radiology department local area network.
Ask a Question
K Number
K061920Device Name
NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAER
Manufacturer
NOVARAD CORP.
Date Cleared
2006-08-21
(46 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NOVARAD CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Picture Archiving and Communications for presenting images and information from the modalities to radiologists or others for reading. Includes standard viewing tools made to help the radiologist or cardiologist or others organize the images and read them in an efficient and easy manner.
Device Description
The PACS product provides a system where images and accompanying data are sent from the modalities to the radiologists and technologists in digital format. The images are then viewed on a computer with such available tools a window, level, zoom, pan, roi, digital subtraction, ejection fraction, cross localize, and many other similar tools and with the ability to make notes and dictate a report. The images and report are then stored long term on a digital archive with multiple redundancy. All the information is also made available as a web based product where referring physicians or radiologists can access the information from anywhere using a secure system. The software is provided by NovaRad along with some 3 party software, principally from windows, and resides on off-the-shelf hardware hooked up to the radiology department local area network.
Ask a Question
Page 1 of 1