Flying Diagnostic Ultrasound System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K083877 FDA 510(k)
- FDA Product Code
- ITX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1570 FDA 510(k)
- Regulation Number
- 892.1570 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Flying Diagnostic Ultrasound System is a portable diagnostic ultrasound device classified under the Radiology category. It is designed to provide real-time imaging for diagnostic purposes, enabling clinicians to visualize internal body structures such as organs, tissues, and blood flow using high-frequency sound waves. This system is intended for use in various clinical settings where mobility and accessibility are critical, including emergency response, field diagnostics, and underserved areas.
This device is supplied as a single-use or reusable system (as determined by facility protocols) and is intended for use in non-MRI environments. It is cleared by the FDA under 510(k) clearance (K083877) and falls under the ITX product code for radiology devices. Storage and handling must comply with manufacturer guidelines to ensure optimal performance and sterility where applicable. No specific size or sterility classification is explicitly stated in the regulatory data.
Frequently asked questions
Is the Flying Diagnostic Ultrasound System designed for use in MRI environments?
No, the device is explicitly intended for use in non-MRI environments only. This is stated in the manufacturer’s guidelines to ensure compatibility and safety, as MRI environments require specialized equipment to avoid interference or damage from magnetic fields.
How is the Flying Diagnostic Ultrasound System supplied, and can it be reused?
The system is supplied with flexibility in usage—facilities can determine whether to use it as a single-use or reusable device based on their protocols. The regulatory data does not prescribe a single method, so reprocessing (if reused) must follow the manufacturer’s instructions to maintain performance and sterility where applicable.
What clinical settings is this device most suited for, and why?
The device is optimized for mobile and accessible diagnostics, making it ideal for emergency response, field diagnostics, and underserved areas where portability and real-time imaging are critical. Its design emphasizes mobility, enabling clinicians to perform ultrasounds outside traditional hospital settings without compromising diagnostic quality.
Does the device include any specific size or model variations, and how might that affect selection?
The regulatory data does not specify particular size or model variations for the Flying Diagnostic Ultrasound System. However, since it’s a portable radiology device, its compact design likely supports various clinical needs, though exact configurations (e.g., probe types, display sizes) would require consultation with the manufacturer or product documentation for precise compatibility with workflows.
What storage and handling precautions should be taken to ensure the device remains functional?
The manufacturer’s guidelines must be followed for storage and handling to maintain optimal performance, though no explicit details are provided in the regulatory data. For reusable units, this would include cleaning, sterilization (if applicable), and environmental controls to prevent damage. Single-use units would require adherence to disposal protocols to avoid contamination or misuse.
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. Sources consulted: Neusoft Medical-Home, FLYING DIAGNOSTIC ULTRASOUND SYSTEM (K083877) — FDA 510 (k) - Innolitics, Neusoft Medical Systems Flying Ultrasound - allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K083877 | Class II | Active |
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Manufacturer
- Manufacturer
- Neusoft Medical Systems Co., Ltd.
Sources (1)
- FDA 510(k) K083877 24 fields · synced Sep 19, 2026