Paragon XHD Diagnostic Ultrasound System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191347 FDA 510(k)
- FDA Product Code
- IYN 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 Paragon XHD Diagnostic Ultrasound System is a diagnostic ultrasound system classified under product code IYN, which covers pulsed Doppler and ultrasound imaging systems. It is a Class II medical device subject to special controls, as determined by its FDA 510(k) clearance.
The system was cleared via the traditional 510(k) pathway under K191347, with a decision of substantially equivalent issued on February 7, 2020. It is manufactured by Shenzhen Wisonic Medical Technology Co., Ltd. and is authorized for distribution in the United States under FDA 510(k) clearance.
Frequently asked questions
What is the Paragon XHD Diagnostic Ultrasound System used for?
The Paragon XHD Diagnostic Ultrasound System is used for pulsed Doppler and ultrasound imaging, as indicated by its FDA product code IYN classification for diagnostic ultrasound systems.
How is the Paragon XHD Diagnostic Ultrasound System regulated in the United States?
The Paragon XHD Diagnostic Ultrasound System is regulated as a Class II medical device under FDA 510(k) clearance K191347, which was granted on February 7, 2020, following a traditional 510(k) review and a determination of substantial equivalence.
Who manufactures the Paragon XHD Diagnostic Ultrasound System and where is it made?
The Paragon XHD Diagnostic Ultrasound System is manufactured by Shenzhen Wisonic Medical Technology Co., Ltd., located at 1st, 2nd & 5th Floor, #6 Bldg., Pingshan Tech Park, Taoyuan St., Nanshan, Shenzhen, China, with postal code 518055.
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: Paragon XHD Diagnostic Ultrasound System (K191347) — FDA 510 (k ..., Shenzhen Wisonic Paragon XHD Ultrasound - allmed.wiki, K191347 FDA 510(k) - Paragon XHD Diagnostic Ultrasound System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191347 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Wisonic Medical Technology Co., Ltd.
- FDA Applicant
- Shenzhen Wisonic Medical Technology Co. , Ltd.
Sources (1)
- FDA 510(k) K191347 24 fields · synced Oct 6, 2026