Selenia Full Field Digital Mammography System

• • Ongoing Z-2167-2026 FDA Class II ·initiated 8 Apr 2026

  Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

• • Terminated Z-1700-2014 FDA Class II ·initiated 13 May 2014

  Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury

• • Terminated Z-2301-2013 FDA Class II ·initiated 6 Sep 2013

  Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images

• • Terminated Z-1546-2008 FDA Unclassified (pre-2012) ·initiated 28 Feb 2008

  Marker Misalignment: The new software version contained a magnification factor that shows CAD markers misaligned with the identified indications. The marked area is misaligned up to 2cm from the indication.

Full name

Hologic Selenia Full Field Digital Mammography System

Trade Name

Lorad Digital Breast Imager

Generic Name

Full field digital, system, x-ray, mammographic

PMA Number

P010025 ↗

FDA Product Code

MUE

Device Class

Class II

Regulation

21 CFR Part 892.1715

Advisory Committee

Radiology

FDA Decision

APRL

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• Is the Hologic Selenia Full Field Digital Mammography System intended for single-use or reusable in clinical settings?

  The Hologic Selenia Full Field Digital Mammography System is designed as a reusable medical device. It is built for repeated use in radiology departments, ensuring durability and compatibility with existing workflows for breast cancer screening and diagnosis.

• What regulatory pathway was followed for the approval of this mammography system?

  The Hologic Selenia system was approved through the FDA Premarket Approval (PMA) process, with PMA number P010025. This pathway is typically used for high-risk medical devices, ensuring rigorous evaluation of safety and effectiveness before market authorization.

• How does the Selenia system compare to traditional screen-film mammography systems in terms of imaging quality?

  The Selenia system generates high-resolution digital mammographic images that are designed to be comparable to traditional screen-film mammography systems. It maintains compatibility with existing diagnostic protocols, allowing radiologists to integrate it seamlessly into their workflow for breast cancer screening and diagnosis.

• What clinical applications is this device intended for, and where would it typically be used?

  The Selenia system is intended for breast cancer screening and diagnosis, functioning identically to traditional screen-film mammographic systems. It is used in radiology departments for breast imaging, ensuring continuity with established diagnostic practices.

• Does the Selenia system require any special handling or storage conditions?

  Since the Selenia system is a reusable medical device, proper cleaning, maintenance, and storage protocols must be followed to ensure functionality and sterility between uses. While specific storage conditions aren’t detailed in the data, standard radiology equipment care—such as protection from moisture and physical damage—should be observed.