System, X-Ray, Angiographic

Who Makes This Device Type in China?

7 manufacturers in China hold an FDA registration for this device type, concentrated in Beijing, Guangdong and Shanghai, and 1 other province.

Arthrex (Shanghai) Co., Ltd. Shanghai
GE Hangwei Medical Systems Co., Ltd. Beijing
GE Healthcare (China) Co., Ltd. Beijing
Guangdong Optomedic Technologies, Inc. Guangdong
Scivita Medical Technology Co., Ltd. Jiangsu
Siemens Shanghai, Medical Equipment Ltd. Shanghai, contract manufacturer
Zhuhai Dipu Medical Technology Co., Ltd. Guangdong

What Is FDA Product Code IZI?

System, X-Ray, Angiographic is FDA product code IZI, Class 2, 21 CFR 892.1600.

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

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Do the Recalls Say?

The FDA has recorded 259 recalls under this product code since 2002. None was by a company in China. The root causes the FDA records most often are Software design (56), Device Design (56) and Nonconforming Material/Component (26).

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

System, X-Ray, Angiographic

Endoro DR ES70 X-Ray Source

Catalogue number ES70, listed by Remedi Inc., South Korea, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

pde-neoII

Catalogue number C10935-400, listed by Hamamatsu Photonics K.K., Japan, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

InfiMed I5, RF, CCD Camera

Catalogue number i5 RF, listed by Infimed, Inc., United States, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

Innova

Innova IGS 620 002 UDI

System, X-Ray, Angiographic

Artis Genio Floor

Catalogue number 11832100, listed by Siemens Healthcare Limited, Canada, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

Endowrist SP

Camera, 0°

System, X-Ray, Angiographic

Davinci Si

Fluorescence Imaging Camera Head AND Cable KIT

System, X-Ray, Angiographic

FL400 / FL560

FL400 / FL560 for M530 - Accessory for Leica surgical operating microscope systems

System, X-Ray, Angiographic

SPY

SPY2000 drug and drape kit

System, X-Ray, Angiographic

Enduro DR

Catalogue number ES70, listed by Remedi Inc., South Korea, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

Yellow 560

for OPMI PENTERO 800 and OPMI PENTERO 900

System, X-Ray, Angiographic

Leica GLOW800

Catalogue number 000000000010448962, listed by Leica Microsystems (Schweiz) AG, Switzerland, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

SPY-PHI System

SPY-PHI Handheld Imager

System, X-Ray, Angiographic

Leica FL800

3 catalogue numbers from 000000000010448713, listed by Leica Microsystems (Schweiz) AG, Switzerland, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

Alpine Stirrups, Metric, Right

Catalogue number RT-5100-54R-CE, listed by Qfix, United States, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

Alpine Stirrups, Metric, Left

Catalogue number RT-5100-54L-CE, listed by Qfix, United States, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

System, X-Ray, Angiographic

FCS1200 Fluid Collection System

System, X-Ray, Angiographic

Aeos

Software Module DIR 800

System, X-Ray, Angiographic

Infrared AND Blue Light Filter Unit

Catalogue number MAJ-2308, listed by Olympus Medical Systems Corp., Japan, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

Artis Zee Biplane

Catalogue number 10094141, listed by Siemens Healthcare Limited, Canada, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

Modus IR

Modus IR is a fluorescence imaging accessory used with the Synaptive Surgical Exoscope. With indocyanine green, it helps visualize vessels and blood flow in the cerebrovasculature before,…

System, X-Ray, Angiographic

Artis Q Floor

Catalogue number 10848280, listed by Siemens Healthcare Limited, Canada, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

Artis Q Ceiling

Catalogue number 10848281, listed by Siemens Healthcare Limited, Canada, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

Leica FL560 for M530

Catalogue number 000000000010448795, listed by Leica Microsystems (Schweiz) AG, Switzerland, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

Bransist Safire

Catalogue number 503-67100-28, listed by Shimadzu Corp., United States, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

Artis Q.zen Floor

Catalogue number 10848353, listed by Siemens Healthcare Limited, Canada, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

Dornier MedTech

Nonsterile Equipment Large Cover for the Movement Footswitch 26” x 26”

System, X-Ray, Angiographic

DeRoyal

Syringe 10CC Adenosine Purple 50C

System, X-Ray, Angiographic

SPY PAQ

Catalogue number LC3006, listed by Novadaq Technologies, Inc., Canada, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

IGS WF BP

IGS WF BP: 1 catalogue number listed by GE Medical Systems, LLC, United States, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

Alpine Stirrups

Stirrup, Right

System, X-Ray, Angiographic

Medline

Squeeze,cms,bulk,n-S,PG

System, X-Ray, Angiographic

Remex KA6

Catalogue number REMEX KA6, listed by Remedi Inc., South Korea, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

Explorer AIR II

EXPLORER AIR® II consists of an imaging system that contains two cameras (one (1) for fluorescence, one (1) for color images) suspended by an articulated arm attached to a trolley. A touch…

System, X-Ray, Angiographic

Allia

Allia Moveo UDI

System, X-Ray, Angiographic

Artis Zee Floor MN

Catalogue number 10094142, listed by Siemens Healthcare Limited, Canada, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

Artis Icono Ceiling

Catalogue number 11328100, listed by Siemens Healthcare Limited, Canada, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

Artis Q.zen Ceiling

Catalogue number 10848354, listed by Siemens Healthcare Limited, Canada, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

PDE-GEN3

Catalogue number C13999-40, listed by Hamamatsu Photonics K.K., Japan, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

GLOW800

GLOW800 - Accessory for Leica surgical operating microscope systems

System, X-Ray, Angiographic

Optima

Optima IGS Ultra UDI

System, X-Ray, Angiographic

System, X-Ray, Angiographic

Endoscope, Firefly

System, X-Ray, Angiographic

Namic

NAMIC Squeeze Contrast Controller 72" Tubing Assembly

System, X-Ray, Angiographic

iMRX System

iMRX System POSTERIOR ASSY, 3T 16CH CARDIAC COIL, 105589-000

System, X-Ray, Angiographic

Control Syringe

12cc Soft Touch Control Syringe FG/PP/RA w/Reservoir

System, X-Ray, Angiographic

Leica FL800 ULT

2 catalogue numbers from 000000000010449023, listed by Leica Microsystems (Schweiz) AG, Switzerland, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

Infrared 800 With Flow® 800 Option

2 catalogue numbers from 7012, listed by Carl Zeiss Meditec Inc, United States, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.

System, X-Ray, Angiographic

Med-Syringe

10cc Med Syringe L/L Dark Green Contrast

System, X-Ray, Angiographic

Luna

LUNA Fluorescence Angiography System with SPY-QCM

System, X-Ray, Angiographic

Namic

MTO BAG Contrast Bottle Hanger 50CC PG

System, X-Ray, Angiographic

Sterimed

3 Piece Tray Cover Pack - 1 - 24” X 28” Clear, 1 - 24” X 28” Red, 1 - 34” X 30” Clear (TC3B) Non-Sterile

System, X-Ray, Angiographic

Novadaq and Pinpoint

Pinpoint Laparoscope - 10mm, Standard, 45 with Wolf and Storz adaptor

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer