SERV MEDICAL CDSS
Serv Medical Pte. LtdSERV MEDICAL CDSS is a medical image processing software designed for trained professionals, enabling viewing, processing, and analysis of imaging data acquired with Digital Subtraction Angiography (DSA). It helps clinicians visualize large vessels and supports clinical decision making by providing comprehensive image viewing and analysis capabilities on standard hardware.
Intended Use
SERV MEDICAL CDSS is an image processing software package to be used by trained professionals, including, but not limited to physicians and medical technicians, for image viewing, processing and analysis of images acquired through DICOM compliant imaging devices with DSA (Digital Subtraction Angiography). Not intended for mobile diagnostic use.
Technology
SERV MEDICAL CDSS is a medical image visualization and processing software compliant with the DICOM standard. It runs on off-the-shelf physical or virtual servers and supports transfer of DSA scans from PACS for visualization and analysis. The software enables basic image viewing, processing, and manipulation functions, providing viewing and analysis of DSA imaging datasets.
Performance
Software verification and validation were conducted, demonstrating that all software requirements were met and hazards mitigated. The device has a safety and effectiveness profile similar to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/5/2024
8 months - 2
FDA Approval
3/17/2025
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