Manufacturer

Suzhou Powersite Electric

ChinaLegal entities : Suzhou Powersite Electric Co., Ltd.

Markets : Germany · Italy · United States

Approvals : EU – class IIb · United States (FDA) – 510(k) : 1 · class I, II · latest in 2022 · see on the FDA website

EU representative : MedPath GmbH (Germany)

1 category, 4 models including 4 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
High voltage X-ray generators	Z11039011	Combined High Frequency X-Ray Source PSM-PD3.5CPE, PSM-PD4CPE, PSM-PD5.6CPE, PSM-PD3.5CPEG, PSM-PD4CPEG, PSM-PD5.6CPEG3 refs Medical X-ray High Frequency High Voltage Generator PSG-HR32, PSG-HR40, PSG-HR50, PSG-HR65, PSG-HR803 refs Medical X-ray Radiography Fluoroscopy High Frequency High Voltage Generator PSG-RF50, PSG-RF65, PSG-RF803 refs Mobile Medical X-ray High Frequency High Voltage Generator PSG-M50LD, PSG-M40LD, PSG-M32LD, PSG-M50HD, PSG-M40HD, PSG-M32HD3 refs	IIb MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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