Monitor, Patient Position, Light-Beam

Who Makes This Device Type in China?

5 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Shandong and Shanghai.

Guangdong Meicen Medical Equipment Co., Ltd. Guangdong
Infitek Co., Ltd. Shanghai
Labpeak Co., Ltd. Shandong
Scitek Global Co., Ltd. Shandong
Shenzhen Tengfei YU Technology Co., Ltd. Guangdong

How Is IWE Classified?

Monitor, Patient Position, Light-Beam is FDA product code IWE, Class 1, 21 CFR 892.5780.

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.

What Do the Recalls Say?

The FDA has recorded 8 recalls under this product code since 2009. None was by a company in China. The root causes the FDA records most often are Radiation Control for Health and Safety Act (2), Device Design (2) and Labeling design (1).

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

Monitor, Patient Position, Light-Beam

Cross-Hair Reticule, Radiation Opaque

Catalogue number 54-224, listed by Aktina Medical Corp., United States, under Monitor, Patient Position, Light-Beam. 5 manufacturers in China are registered for this product code.

Monitor, Patient Position, Light-Beam

Head & Neck Laser Alignment Tool

Head & Neck Laser Alignment Tool is an apparatus for assisting pharyngeal/upper airway general purposed ultrasound scan. The apparatus can align the position of head and the general…

Monitor, Patient Position, Light-Beam

Rayshield

6" Laserx C-ARM Image Intensifier Aimer

Monitor, Patient Position, Light-Beam

Port Film Graticule, Siemens Compatible

Catalogue number 54-044, listed by Aktina Medical Corp., United States, under Monitor, Patient Position, Light-Beam. 5 manufacturers in China are registered for this product code.

Monitor, Patient Position, Light-Beam

Cross-Hair Reticule, Xretic

Catalogue number 54-225, listed by Aktina Medical Corp., United States, under Monitor, Patient Position, Light-Beam. 5 manufacturers in China are registered for this product code.

Monitor, Patient Position, Light-Beam

Open Air Graticule, 2cm, Elekta Compatible

Catalogue number 11-346, listed by Aktina Medical Corp., United States, under Monitor, Patient Position, Light-Beam. 5 manufacturers in China are registered for this product code.

Monitor, Patient Position, Light-Beam

Graticule, PTW David Mount

Catalogue number 11-346-C1, listed by Aktina Medical Corp., United States, under Monitor, Patient Position, Light-Beam. 5 manufacturers in China are registered for this product code.

Monitor, Patient Position, Light-Beam

Gradic Port Film Graticule, Siemens Compatible

Catalogue number 54-045, listed by Aktina Medical Corp., United States, under Monitor, Patient Position, Light-Beam. 5 manufacturers in China are registered for this product code.

Monitor, Patient Position, Light-Beam

Port Film Graticule, Tray Mount, Elekta Compatible

Catalogue number 11-345, listed by Aktina Medical Corp., United States, under Monitor, Patient Position, Light-Beam. 5 manufacturers in China are registered for this product code.

Monitor, Patient Position, Light-Beam

Port Film Graticule, Latch Mount, Elekta Compatible

Catalogue number 11-344, listed by Aktina Medical Corp., United States, under Monitor, Patient Position, Light-Beam. 5 manufacturers in China are registered for this product code.

Monitor, Patient Position, Light-Beam

Cross-Hair Reticule, Open-Air

Catalogue number 54-227, listed by Aktina Medical Corp., United States, under Monitor, Patient Position, Light-Beam. 5 manufacturers in China are registered for this product code.

Monitor, Patient Position, Light-Beam

Apollo

10 catalogue numbers from APOLLO red cross-hair, listed by L A P Gmbh Laser Applikationen, under Monitor, Patient Position, Light-Beam. 5 manufacturers in China are registered for this product code.

Monitor, Patient Position, Light-Beam

Open Air Graticule, 1cm, Elekta Compatible

Catalogue number 11-346-M1, listed by Aktina Medical Corp., United States, under Monitor, Patient Position, Light-Beam. 5 manufacturers in China are registered for this product code.

Monitor, Patient Position, Light-Beam

Astor

6 catalogue numbers from ASTOR green line 90°, listed by L A P Gmbh Laser Applikationen, under Monitor, Patient Position, Light-Beam. 5 manufacturers in China are registered for this product code.

Monitor, Patient Position, Light-Beam

Huestis Centralite Patient Positioning Laser

KIT Contains 2 DLG-2 Green Cross Lasers, 1 DLG-4 Green Sagittal Laser

Monitor, Patient Position, Light-Beam

HIT Laser

Laser Box Product Number: HW001 laser Product number: HW049, HW050

Monitor, Patient Position, Light-Beam

Aadco

Single Mount Monitor Adapter W/ Handle 5-18KG W/Internal Wiring

Monitor, Patient Position, Light-Beam

MRI-Safe

Single LCD Mount W/ ARM AND Dual Column Internal Wiring MRI Safe

Monitor, Patient Position, Light-Beam

Dorado

20 catalogue numbers from DORADO red wall, listed by L A P Gmbh Laser Applikationen, under Monitor, Patient Position, Light-Beam. 5 manufacturers in China are registered for this product code.

Monitor, Patient Position, Light-Beam

Simulator Dot Reticle Set

Catalogue number 54-883, listed by Aktina Medical Corp., United States, under Monitor, Patient Position, Light-Beam. 5 manufacturers in China are registered for this product code.

Monitor, Patient Position, Light-Beam

Carina

10 catalogue numbers from CARINAnav, listed by L A P Gmbh Laser Applikationen, under Monitor, Patient Position, Light-Beam. 5 manufacturers in China are registered for this product code.

Monitor, Patient Position, Light-Beam

Sun Nuclear Micro+ MR

The MICRO+ MR MLR+300 Laser is used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. This product is used in medical…

Monitor, Patient Position, Light-Beam

Centralite Patient Positioning Laser

Moving Laser Handheld Pendant with holster and cable

Monitor, Patient Position, Light-Beam

CT Sim+

The CT Sim+, 3-Arm, Green Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation…

Monitor, Patient Position, Light-Beam

Hercules

Single LCD Screen MT W/ ARM & Dual Column (Monitor Wght 10 - 16 KG)

Monitor, Patient Position, Light-Beam

Meicen

3.0mm Head & Shoulder Reinforced, Freeview Small Opening, S-type EMRT-8388

Monitor, Patient Position, Light-Beam

Sun Nuclear Micro+

The MICRO MLG 200 lasers are intended to be used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. The micro lasers are…

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