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    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025

    MAGNETOM Verio Dot. Model Number: 10684333.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025