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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 5 of 5 Results
510(K) Number: K152294
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FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull... 2 05/24/2024 FEI # 1000513161
FUJIFILM Healthcare Americas Corporation
FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-1613... 2 10/07/2025 FEI # 1000513161
FUJIFILM Healthcare Americas Corporation
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3) 2 02/05/2026 FEI # 1000513161
FUJIFILM Healthcare Americas Corporation
FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing N... 2 12/10/2017 FEI # 1000513161
Fujifilm Medical Systems U.S.A., Inc.
SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking gen... 2 06/29/2017 FEI # 1000125362
Shimadzu Medical Systems Usa Com
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