Device, Beam Limiting, X-Ray, Diagnostic

Which Manufacturers in China Make This?

2 manufacturers in China hold an FDA registration for this device type, based in Shanghai and Zhejiang.

Fairy Medical Electrics(Jiaxing)Co., Ltd. Zhejiang
Siemens Shanghai, Medical Equipment Ltd. Shanghai, contract manufacturer

How Is KPW Classified?

Device, Beam Limiting, X-Ray, Diagnostic is FDA product code KPW, Class 2, 21 CFR 892.1610.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

Device, Beam Limiting, X-Ray, Diagnostic

Collimator ML01 II

Catalogue number 10092611, listed by Siemens Healthcare Limited, Canada, under Device, Beam Limiting, X-Ray, Diagnostic. 2 manufacturers in China are registered for this product code.

Device, Beam Limiting, X-Ray, Diagnostic

X-Ray Beam Filter Kit

4X4 X-ray Beam Filter Kit

Device, Beam Limiting, X-Ray, Diagnostic

Philips Medical Systems DMC

Catalogue number Juno DRF, listed by Villa Sistemi Medicali SPA, under Device, Beam Limiting, X-Ray, Diagnostic. 2 manufacturers in China are registered for this product code.

Device, Beam Limiting, X-Ray, Diagnostic

Collimator AL02 II El

Catalogue number 10092614, listed by Siemens Healthcare Limited, Canada, under Device, Beam Limiting, X-Ray, Diagnostic. 2 manufacturers in China are registered for this product code.

Device, Beam Limiting, X-Ray, Diagnostic

Villa Sistemi Medicali

2 catalogue numbers from Apollo EZ DRF, listed by Villa Sistemi Medicali SPA, under Device, Beam Limiting, X-Ray, Diagnostic. 2 manufacturers in China are registered for this product code.

Device, Beam Limiting, X-Ray, Diagnostic

Catalogue number YS-3GA, listed by Yoshida Denzai Kogyo Co., Ltd., under Device, Beam Limiting, X-Ray, Diagnostic. 2 manufacturers in China are registered for this product code.

Device, Beam Limiting, X-Ray, Diagnostic

X-Ray Beam Limiting Device

Catalogue number BLR-15AA, listed by Canon Inc., Japan, under Device, Beam Limiting, X-Ray, Diagnostic. 2 manufacturers in China are registered for this product code.

Device, Beam Limiting, X-Ray, Diagnostic

Ralco Srl

10 catalogue numbers from R 302 MLP/A DHHS, listed by Ralco SRL, under Device, Beam Limiting, X-Ray, Diagnostic. 2 manufacturers in China are registered for this product code.

Device, Beam Limiting, X-Ray, Diagnostic

Which Manufacturers in China Make This?

How Is KPW Classified?

What Does It Take to Sell It in the United States?

Where China Actually Supplies