Collimator, Automatic, Radiographic

Who Makes This Device Type in China?

5 manufacturers in China hold an FDA registration for this device type, concentrated in Beijing, Zhejiang and Jiangsu.

Fairy Medical Electrics(Jiaxing)Co., Ltd. Zhejiang
GE Hangwei Medical Systems Co., Ltd. Beijing
GE Healthcare (China) Co., Ltd. Beijing
Suzhou Shangchuang Technology Service Co., Ltd. Jiangsu
iRay Imaging Technology (Haining) Limited Zhejiang, contract manufacturer

How Is IZW Classified?

Collimator, Automatic, Radiographic is FDA product code IZW, Class 2, 21 CFR 892.1610.

How Does It Reach the US Market?

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.

What Do the Recalls Say?

The FDA has recorded 3 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (1) and Device Design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Collimator, Automatic, Radiographic

Collimator Cradle 512 Asm

The collimator is intended for a larger compression height range with breasts of larger size.

Collimator, Automatic, Radiographic

R-300

2 catalogue numbers from 566-17970-85, listed by Shimadzu Corp., United States, under Collimator, Automatic, Radiographic. 5 manufacturers in China are registered for this product code.

Collimator, Automatic, Radiographic

Vareximaging

x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(Collimator) This is a device of the Optica 40 series.

Collimator, Automatic, Radiographic

Iray

Catalogue number CRUX RF10, listed by iRay Imaging Technology (Haining) Limited, China, under Collimator, Automatic, Radiographic. 5 manufacturers in China are registered for this product code.

Collimator, Automatic, Radiographic

Ralco Srl

9 catalogue numbers from R 225 ACS DHHS, listed by Ralco SRL, under Collimator, Automatic, Radiographic. 5 manufacturers in China are registered for this product code.

Collimator, Automatic, Radiographic

Linear IV

R40-CS-P LIN IV Collimator W/65 FT Cable

Collimator, Automatic, Radiographic

Claymount

x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(Collimator) This is a device out of the Optica 30 series

Collimator, Automatic, Radiographic

Varex Imaging

x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(Collimator) This is a device out of the Optica 40 series

Collimator, Automatic, Radiographic

Who Makes This Device Type in China?

How Is IZW Classified?

How Does It Reach the US Market?

What Do the Recalls Say?

Where China Actually Supplies