Tomoscan SR5000

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

Full name

Philips Tomoscan SR5000

510(k) Number

K944326 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Philips Medical Systems North America, Inc. →

• What is the primary clinical use of the Philips Tomoscan SR5000 in breast imaging, and how does its technology differ from traditional mammography?

  The Philips Tomoscan SR5000 is designed for high-resolution breast imaging using tomosynthesis, a technique that creates detailed cross-sectional images of breast tissue. Unlike traditional mammography, which provides a single two-dimensional image, this device captures multiple angled images to reconstruct a 3D view. This helps improve the visualization of microcalcifications and soft-tissue structures, reducing overlap and enhancing diagnostic accuracy for conditions like breast cancer.

• Is the Philips Tomoscan SR5000 a single-use or reusable device, and what maintenance is required to ensure proper functionality?

  The Philips Tomoscan SR5000 is a reusable medical imaging system, meaning it is intended for repeated use in radiology departments. To maintain its performance, it requires regular maintenance and calibration as outlined by Philips Medical Systems. This includes technical checks, software updates, and adherence to manufacturer guidelines to ensure imaging accuracy and reliability over time.

• What regulatory pathway was followed for FDA clearance of the Philips Tomoscan SR5000, and what does the product code JAK indicate?

  The Philips Tomoscan SR5000 received FDA clearance through a 510(k) submission (K-number K944326), classified under product code JAK, which falls under the Radiology advisory committee. The clearance was granted under the Traditional 510(k) Review pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. The product code JAK specifically categorizes breast imaging devices, confirming its intended use in mammography and tomosynthesis applications.

• Can this device be used in an MRI environment, or are there any safety considerations related to magnetic fields?

  The Philips Tomoscan SR5000 is not labeled as MRI-safe or MRI-conditional, meaning it should not be used in an MRI environment. Its design does not account for magnetic interference or electromagnetic compatibility with MRI systems, so precautions must be taken to avoid exposure to magnetic fields that could compromise its functionality or pose safety risks.