Shimadzu Catheterization C-Arm Stand ER-200

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K875372 ↗

FDA Product Code

IZI

Device Class

Class II

Regulation

21 CFR Part 892.1600

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K801957 Active Cleared 26 Sep 1980

• Shimadzu Mammographic Stand Mr-30

  Class II

  FDA 510(k) K875377 Active Cleared 12 Feb 1988

• Shimadzu Whole Body X-Ray CT Scanner Sct-3000TX

  Class II

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• Sdu 800 Diagnostic Ultrasound Instrument

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  FDA 510(k) K890913 Active Cleared 6 Sep 1989

• Shimadzu X-Ray High Voltage Generator UD150K

  Class I

  FDA 510(k) K881795 Active Cleared 1 Jul 1988

• Shimadzu Digital Subtraction System Dar-1200

  Class II

  FDA 510(k) K884598 Active Cleared 20 Apr 1989

See all devices from Shimadzu Precision Instruments, Inc. →

• What is the Shimadzu ER-200 Catheterization C-Arm Stand used for?

  The Shimadzu ER-200 Catheterization C-Arm Stand is designed specifically for angiographic procedures in catheterization labs. It delivers mobile fluoroscopic imaging to help clinicians visualize blood vessels, cardiac structures, and vascular interventions in real time. This real-time imaging supports precise diagnostic and therapeutic interventions, such as coronary angiography, peripheral vascular studies, and other interventional radiology techniques.

• Is the Shimadzu ER-200 Catheterization C-Arm Stand reusable or single-use?

  The Shimadzu ER-200 Catheterization C-Arm Stand is supplied as a reusable medical instrument. Unlike single-use devices, it is intended for repeated use in clinical settings, provided it undergoes proper maintenance and cleaning as specified by the manufacturer. This design allows for cost-effective deployment in radiology departments and catheterization labs.

• What are the key features of the ER-200 model?

  The ER-200 model is distinguished by its C-arm configuration, which enables flexible positioning around patients. This design is particularly advantageous in catheterization labs, where mobility and adaptability are critical for performing procedures such as coronary angiography or peripheral interventions. The C-arm’s ability to rotate and pivot around the patient ensures comprehensive imaging coverage during complex interventions.

• How should the Shimadzu ER-200 be stored and maintained?

  Storage and maintenance requirements for the Shimadzu ER-200 are manufacturer-specific, meaning they are detailed in the device’s user manual or technical documentation provided by Shimadzu Precision Instruments. Proper storage typically involves keeping the device in a clean, dry environment to prevent damage or contamination. Maintenance may include regular calibration, cleaning, and inspection to ensure optimal performance and compliance with regulatory standards. Always follow the manufacturer’s guidelines to extend the device’s lifespan and ensure patient safety.

• Is the Shimadzu ER-200 Catheterization C-Arm Stand suitable for MRI environments?

  The available data does not specify MRI safety for the Shimadzu ER-200 Catheterization C-Arm Stand. If used in or near an MRI environment, it is critical to verify compatibility with the MRI system’s magnetic field strength and radiofrequency emissions to avoid interference or safety hazards. Always consult the manufacturer’s documentation or seek expert advice before integrating this device into an MRI facility.