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Digital Color Doppler Ultrasound System - Autra Senior

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K254028

by Sonoscape Medical Corp.

Identifiers

510(k) Number
K254028 FDA 510(k)
FDA Product Code
IYN FDA 510(k)
Models / Variants
Autra RS FDA 510(k)EUDAMED
Autra 90 FDA 510(k)EUDAMED
Autra Senior FDA 510(k)EUDAMED
Autra CV FDA 510(k)EUDAMED
e-Autra FDA 510(k)EUDAMED
Autra 75 FDA 510(k)EUDAMED
Autra 85W FDA 510(k)EUDAMED
Autra 65 FDA 510(k)EUDAMED
Autra 55 FDA 510(k)EUDAMED
Autra 65i FDA 510(k)EUDAMED
Autra 90 Elite FDA 510(k)EUDAMED
Autra 85 Elite FDA 510(k)EUDAMED
Autra 80 Elite FDA 510(k)EUDAMED
Autra 75 Elite FDA 510(k)EUDAMED
Autra 85 CV FDA 510(k)EUDAMED
Autra 80W FDA 510(k)EUDAMED
Autra 65 Elite FDA 510(k)EUDAMED
Autra 55 Elite FDA 510(k)EUDAMED
Autra 55i FDA 510(k)EUDAMED
Autra 90 CV FDA 510(k)EUDAMED
Autra 85 FDA 510(k)EUDAMED
Autra 80 FDA 510(k)EUDAMED
Autra 80 CV FDA 510(k)EUDAMED
Autra 75 Pro FDA 510(k)EUDAMED
Autra 75W FDA 510(k)EUDAMED
Autra 70 Elite FDA 510(k)EUDAMED
Autra 70 FDA 510(k)EUDAMED
Autra T FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1550 FDA 510(k)
Regulation Number
892.1550 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Digital Color Doppler Ultrasound System is a diagnostic imaging device designed for vascular and cardiac assessment. It employs Doppler ultrasound technology to visualize blood flow within vessels and organs, providing real-time color mapping to evaluate velocity, direction, and turbulence of blood flow. This aids clinicians in diagnosing conditions such as thrombosis, arterial insufficiency, and congenital heart defects.

The system is supplied as a reusable medical device, intended for use in clinical, hospital, and diagnostic imaging settings. It operates under regulatory authorizations including FDA 510K clearance and MDR compliance, ensuring adherence to safety and performance standards. Models vary in specifications, including Autra RS, Autra 90 Elite, and Autra T, with no indication of MRI compatibility or single-use design. Storage and maintenance instructions are manufacturer-specific and must follow regulatory guidelines.

Frequently asked questions

What types of medical conditions can this Digital Color Doppler Ultrasound System help diagnose?

This system is specifically designed for vascular and cardiac assessment, using Doppler ultrasound technology to visualize blood flow. It helps diagnose conditions like thrombosis, arterial insufficiency, and congenital heart defects by providing real-time color mapping of blood flow velocity, direction, and turbulence.

Is this device intended for single-use or can it be reused in clinical settings?

The Digital Color Doppler Ultrasound System is explicitly described as a reusable medical device, meaning it is meant for repeated use in clinical, hospital, and diagnostic imaging environments. Proper maintenance and cleaning protocols must be followed as per manufacturer guidelines.

What regulatory approvals does this device hold, and how does that affect its use?

The system holds FDA 510(k) clearance and MDR compliance, confirming it meets safety and performance standards for diagnostic imaging in the U.S. and EU markets. These approvals ensure it can be legally used in regulated healthcare settings for its intended vascular and cardiac assessments.

Are there different models available, and how do they differ from one another?

Yes, multiple models exist, including the Autra RS, Autra 90 Elite, Autra T, and others. While the exact specifications vary by model (e.g., performance, features), all share the core capability of Doppler ultrasound imaging for blood flow analysis. The differences are typically detailed in manufacturer documentation, but none are described as MRI-compatible or single-use.

How should this device be stored, and are there any special handling requirements?

Storage and maintenance instructions are manufacturer-specific and must align with regulatory guidelines to ensure optimal performance and safety. Since it is reusable, proper cleaning, calibration, and environmental controls (e.g., temperature, humidity) are critical. Always refer to the manufacturer’s guidelines for precise storage protocols.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sonoscape Medical Corp.

Sources (2)

  • FDA 510(k) K254028 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced Jun 1, 2026