Search Results
Found 1 results
510(k) Data Aggregation
K Number
K102148Device Name
CURIEPACS (DICOM PACS SOFTWARE)
Manufacturer
Date Cleared
2010-08-17
(18 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MOKSHA DIGITAL SOFTWARE PVT LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CuriePACS (Dicom PACS Software) Software is a software device that receives digital images and data from various sources (Computed Radiography, Magnetic Resonance Imaging, Ultrasound, Endoscopy, Computed Tomography, Digital X-Ray Mammography, Nuclear Medicine Imaging, Secondary Capture, Radio Fluoroscopy, X-Ray or other Angiograms such as CT Angio). Images and data can he captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA.
Device Description
CuriePACS is a comprehensive solution for Dicom imaging needs. This scalable PACS solution provides electronic viewing, storage and communication in a secure environment. The device consists of: 1. Dicom Server (MD Athena) - For storage and connectivity with all the modalities and 2. Image Viewer (MD Vision) - To connect to the server and retrieve images based on search criteria and other workflow requirements. Image modalities supported: CR. CT. DX. MG. MR. NM. RF. SC. US. XA (x-ray), and ES.
Ask a Question
Ask a specific question about this device
Page 1 of 1