Digital Color Doppler Ultrasound Imaging System - Digital Color Doppler Ultrasound Imaging System (Readius C6)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243132 FDA 510(k)
- FDA Product Code
- IYN FDA 510(k)
- Models / Variants
- Digital Color Doppler Ultrasound Imaging System (Readius C6) FDA 510(k)
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 Imaging System is an ultrasonic pulsed doppler imaging device that combines continuous wave doppler-effect technology with pulsed-echo effect technology. It is intended to determine stationary body tissue characteristics, such as the depth or location of tissue interfaces, and dynamic tissue characteristics, such as the velocity of blood.
This system is identified by models Readius L15, P8, V6, and C6. The device has received FDA 510(k) clearance as a Class II medical device under product code IYN.
Frequently asked questions
What is the primary function of the Readius ultrasound systems?
These systems utilize a combination of continuous wave and pulsed-echo doppler technology to determine stationary body tissue characteristics, such as the depth or location of tissue interfaces, as well as dynamic characteristics like blood flow velocity.
Which models are included in this series?
The series consists of four distinct models: the Readius L15, Readius P8, Readius V6, and Readius C6.
What is the regulatory status of these imaging systems?
The Digital Color Doppler Ultrasound Imaging System series has received FDA 510(k) clearance as a Class II medical device under product code IYN.
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: Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital ..., Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital ..., Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243132 | Class II | Active |
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Manufacturer
Sources (1)
- FDA 510(k) K243132 24 fields · synced Oct 6, 2026