BreastDevices & AI clearances

FDA Clears Philips Breast MRI Coils for Clinical Use

U.S. FDA2w ago

U.S. FDA clears Philips’ dS Breast and Sentinelle breast MRI coils (7- and 16-channel) via 510(k) for clinical imaging with 1.5T and 3.0T scanners.

  • Clearance covers multiple coil models including dS Breast 7ch, dS Breast 16ch, and Sentinelle Breast configurations.
  • Product code MOS indicates breast coil classification.
  • Manufacturer: Philips Medical Systems Nederland B.V.

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