DAR-8000I

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

510(k) Number

K052076 ↗

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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• Shimadzu Whole Body X-Ray CT Scanner Sct-7000TX

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• Shimadzu X-Ray High-Voltage Generator XUD150K

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• Shimadzu X-Ray High-Voltage Generator XUD150B

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• Shimadzu Whole Body X-Ray Computed Tomography Scanner Sct-7000TX W/Fluro Option

  Class II

  FDA 510(k) K984156 Active Cleared 21 Apr 1999

• MU125M Mobile X-Ray System

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  FDA 510(k) K920393 Active Cleared 6 Apr 1992

See all devices from Shimadzu Medical Systems →

• What is the primary use of the DAR-8000I X-Ray Angiographic System?

  The DAR-8000I is designed for high-performance digital radiography and fluoroscopy, enabling real-time imaging during diagnostic and interventional procedures. Its primary application is angiography, where it provides precise visualization of blood vessels and internal structures. This capability supports critical procedures in radiology, such as coronary angiography, peripheral vascular imaging, and other interventional radiology tasks.

• How is the DAR-8000I supplied and intended for use?

  The DAR-8000I is supplied as a reusable medical device, intended exclusively for clinical environments like hospitals and diagnostic imaging centers. It is not single-use, meaning it undergoes maintenance and cleaning protocols to ensure repeated use in sterile conditions. The system adheres to manufacturer guidelines for storage and maintenance to preserve functionality and sterility over time.

• Does the DAR-8000I support interoperability with other medical imaging systems?

  Yes, the DAR-8000I integrates with DICOM (Digital Imaging and Communications in Medicine) standards, enabling seamless communication and interoperability with other imaging systems. This includes features like DICOM Print Management and Modality Worklist integration, which streamline workflow efficiency and data exchange in radiology departments.

• What regulatory approval does the DAR-8000I hold, and how does it classify?

  The DAR-8000I is FDA-cleared under 510(k) number K052076, classified as a Class II medical device under regulation 892.1600. This classification indicates it poses minimal risk and has undergone substantial equivalence review by the FDA’s Radiology Advisory Committee. The device is intended for use in radiology procedures as specified in its approved indications.

• What types of procedures can the DAR-8000I support in clinical settings?

  The DAR-8000I is optimized for angiography and fluoroscopy, making it suitable for a range of procedures including coronary angiography, peripheral vascular studies, and other interventional radiology tasks. Its advanced digital technology enhances image quality, enabling clinicians to perform precise diagnostic and therapeutic interventions with improved clarity and efficiency.