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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K100094
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FDA Recall
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CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP... 2 05/02/2016 FEI # 1315356
Carestream Health Inc
CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/PO... 2 05/02/2016 FEI # 1315356
Carestream Health Inc
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