Identifiers
- 510(k) Number
- K080049 FDA 510(k)
- FDA Product Code
- IYO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vascuview Ultrasound System is a medical device used for ultrasound imaging. It is designed to provide visual ultrasound capabilities. The system consists of various components, including a probe holder, cord wrap, and table stand.
The Vascuview Ultrasound System is supplied with a medical-grade power supply and power cord. It has received FDA 510(K) clearance. The system is intended for use in a medical setting, with specific details regarding its use, sterility, and storage not provided in the available data.
Frequently asked questions
What is the Vascuview Ultrasound System used for?
The Vascuview Ultrasound System is used for ultrasound imaging in a medical setting, providing visual capabilities for diagnostic purposes.
Is the Vascuview Ultrasound System sterile?
The available data does not provide specific details regarding the sterility of the Vascuview Ultrasound System, it is recommended to consult the manufacturer or user manual for more information.
What components are included with the Vascuview Ultrasound System?
The system consists of various components, including a probe holder, cord wrap, and table stand, and is supplied with a medical-grade power supply and power cord.
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: Escalon Medical Corp. Announces FDA 510(K) Clearance for VascuView(TM ..., Escalon Medical, PDF Dec2 - 7-- Is
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080049 | Class II | Active |
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Manufacturer
- Manufacturer
- Escalon Medical Corp.
Sources (1)
- FDA 510(k) K080049 24 fields · synced Sep 24, 2026