Senoscan Full Field Digital Mammography System

• • Terminated Z-1094-04 FDA Unclassified (pre-2012) ·initiated 21 May 2004

  Existing software may allow Image data to be truncated in the margin of the breast on processed patient images.

• • Terminated Z-0939-04 FDA Unclassified (pre-2012) ·initiated 12 Apr 2004 ·on shared PMA P010017

  X-ray tube may overheat after high usage because of mis-wired thermal switch circuit.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Generic Name

Full field digital, system, x-ray, mammographic

PMA Number

P010017 ↗

FDA Product Code

MUE

Device Class

Class II

Regulation

21 CFR Part 892.1715

Advisory Committee

Radiology

FDA Decision

APRL

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• What clinical applications does the Senoscan Full Field Digital Mammography System support, and how does it differ from traditional film-based systems?

  The Senoscan Full Field Digital Mammography System is designed for both diagnostic and screening mammography, producing radiographic images of the human breast. Unlike traditional film-based systems, it uses digital imaging technology to capture and display images, replacing physical film with electronic detection and processing. This allows for immediate image review, enhanced contrast resolution, and the ability to manipulate images digitally—such as zooming, measuring, and adjusting brightness—without the need for physical film development.

• Is the Senoscan system reusable or single-use, and what are the implications for maintenance and sterilization?

  The Senoscan Full Field Digital Mammography System is explicitly described as a reusable medical device. As a reusable system, it requires proper maintenance protocols to ensure consistent performance and safety. Since it is not single-use, it must be cleaned, inspected, and sterilized according to established radiology department procedures to prevent contamination and maintain image quality. The manufacturer’s guidelines should be followed for specific cleaning and sterilization instructions.

• What regulatory pathway was followed for the approval of this device, and what does its classification mean for healthcare providers?

  The Senoscan system was approved through the FDA’s Premarket Approval (PMA) process, indicated by the PMA number P010017. This pathway is typically used for higher-risk medical devices, and the system is classified as Class II under FDA regulations. For healthcare providers, this means the device has undergone rigorous evaluation to ensure its safety and effectiveness for diagnostic and screening mammography, and it must comply with ongoing regulatory requirements to maintain its approved status.

• How is the Senoscan system supplied, and what should facilities consider when integrating it into their radiology department?

  The Senoscan Full Field Digital Mammography System is supplied as a complete, reusable imaging system intended for use in radiology settings. Facilities should consider factors such as installation space, electrical requirements, and integration with existing PACS (Picture Archiving and Communication Systems) for seamless workflow. Since it replaces film-based systems, training for radiologists and technologists on digital image interpretation and system operation will be necessary to ensure optimal use.