Products / AuraScan / Technical Specifications
Diagnostic Engine
Clinical-grade ultrasound processing core achieving <0.4ms latency for real-time diagnostic accuracy during high-stakes imaging procedures.
Clinical Workflow
Fully ISO 13485 compliant operational flows designed to integrate seamlessly into hospital imaging centers and surgical theaters with maximum uptime.
DICOM Abstraction
Proprietary med-tech middleware decoupling imaging logic from hardware, ensuring IEC 62304 safety compliance across diverse therapeutic frames.
ADVANCED IMAGING ENGINE CORE
AuraScan: Radiology & Cardiology Imaging Software Core • Regulatory Aligned: FDA Class II, CE MDR, ISO 13485 • HIPAA-Secure IT
Superior Diagnostic Imaging Performance
- Elite Clinical Performance: Ultra-Low Latency | Enterprise HIPAA Security | Global Regulatory Alignment
Enterprise Regulatory & Assurance Framework
AuraScan delivers audit-ready clinical performance by adhering to global imaging standards, ensuring peak diagnostic reliability and uncompromising patient safety.
FDA Class II
CE MDR Ready
ISO 13485
IEC 62304
HL7 | DICOM
HIPAA Compliant
Parameter
Technical Specification
Clinical Compliance Detail
Operating Bandwidth
2.0 – 22.0 MHz
Broadband processing optimized for clinical fidelity.
System Dynamic Range
280 dB
High-contrast resolution for near-field tissue detail.
Signal Architecture
64-bit Digital
Zero-loss pathing aligned with IEC 62304 standards.
Regulatory Certifications
FDA Class II | CE MDR
Validated for ISO 13485 software lifecycle protocols.
Data Security
HIPAA & SOC2 Type II
End-to-end PHI encryption and secure telemetry stream.
Implementation & Deployment Model
Standardized, validated rollout so every AuraScan deployment is predictable and audit‑ready.
1. Discovery & Requirements
Joint review of clinical workflows, imaging volumes, infrastructure, and regulatory requirements for each site
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2. Validated Deployment
Controlled rollout with documented test plans, validation reports, and sign‑off aligned with FDA Class II, CE MDR, ISO 13485, and IEC 62304 expectations.
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3. Integration & Training
PACS/RIS/EHR integration, role‑based staff training, and go‑live support with ongoing updates and documentation.
99.99%
Hospital IT Uptime
HIPAA-ready, high-availability ultrasound core for radiology centers.
Class2
Global Certifications
Aligned with FDA Class II, CE MDR, ISO 13485, and IEC 62304 standards.
CORE
Diagnostic Engine Use
Specialized imaging software for cardiology and radiology workflows.