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BreastDevice clearance

Siemens MAMMOMAT B.brilliant Full-Field Digital Mammography System Cleared by FDA

FDA 510(k) — Radiology devices2w ago

FDA cleared the Siemens MAMMOMAT B.brilliant, a new full-field digital mammography system, under 510(k) K253678. The device is classified under product code MUE.

  • Manufacturer: Siemens Medical Solutions USA, Inc.
  • Device: MAMMOMAT B.brilliant, a full-field digital mammography system (product code MUE).
  • Clearance based on substantial equivalence to a predicate device (exact predicate not specified in source).
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