Intended Use
Studycast® is intended to be used by trained medical professionals (e.g. medical technicians and
physicians) for the transmission, storage and presentation of medical images and associated medical
image data, and the transmission, storage, summarization and presentation of medical diagnostic
test results.
Manufacturer Information
Manufacturer: Core Sound Imaging
Address: 5510 Six Forks Road Suite 200, Raleigh, NC 27609
Office: 919.277.0636
Toll-Free: 866.209.3393
System Requirements
Supported Browsers
Studycast supports the following browsers (minimum versions):
Microsoft Edge: 107+
Mozilla Firefox: 102+
Google Chrome: 107+
Safari / iPadOS: 16+
Warnings and Precautions
· Studycast® is intended for use by trained medical professionals only.
· Users are responsible for verifying patient identity, study selection, and image completeness prior
to clinical use and reporting, consistent with local clinical procedures.
· Measurements and calculation tools are intended to support clinical documentation and
interpretation.
· Measurements and calculation tools rely on user input and the quality and calibration of source
image data.
· Studycast® does not provide independently validated or guaranteed measurement accuracy.
· If Studycast® is unavailable due to network or system interruption, users should follow their
organization’s downtime procedures to maintain continuity of care.
Installation and Configuration Instructions
Studycast® is provided as a hosted service. Installation typically consists of:
1. Account provisioning and administrator setup by Core Sound Imaging.
2. User creation and role-based permission assignment by authorized administrators.
3. Site configuration as applicable (e.g., connectivity, integrations, and workflow settings).
4. Validation of access and workflow using test data prior to clinical use.
Device-Specific Safety Information
Studycast® supports the management and presentation of medical images and diagnostic test
results. Safe use depends on:
- Correct user access and permission configuration
- Secure handling of credentials and PHI
- Verification steps by clinical users to prevent selection or association errors
- Appropriate procedures for downtime or connectivity interruptions
Regulatory and Privacy Requirements
- Certified quality management system according to ISO 13485:2016
- Code of Federal Regulations Title 21 Part 820 Quality System Regulations, and parts 11, 803, 806
and 807; and UK Medical Devices Regulations 2002 (SI 2002 No. 618, as amended) - Meets or exceeds standards for HIPAA and PIPEDA
Symbols
| https://app.corestudycast.com/coreweb/assets/6.0.60 /help/index.html | |||
| Studycast® | |||
| Version | Refer to version number in lower left corner of every page | ||
| Core Sound Imaging 5510 Six Forks Road Suite 200 Raleigh, NC 27609 United States | |||
| Veranex UK Limited 2 Jardine House Horrovian Business Village, Bessborough Road Harrow Middlesex HA1 3EX England, United Kingdom | |||
https://www.studycast.com | |||