A Bounded Public DICOM Metadata Audit for UDI-DICOM Evidence Readiness in Medical Imaging Workflows.

Authors

Bin Zhang

Published in

Journal of imaging informatics in medicine. Jul 29, 2026. Epub Jul 29, 2026.

Abstract

The objective of this study is to assess whether selected public Digital Imaging and Communications in Medicine (DICOM) archive series contain archive-observable equipment-identity and Unique Device Identification (UDI)-related metadata needed for a bounded UDI-DICOM evidence-readiness workflow. We performed a metadata-only audit of DICOM headers without loading Pixel Data. The inferential unit was the selected public series, not each instance. The primary Imaging Data Commons (IDC) sample used one selected public series per successful collection, yielding 442 readable instances across 12 selected series. A supplementary sample from The Cancer Imaging Archive (TCIA) added one selected TCGA-BRCA MR series with 49 readable instances. Synthetic controls, local Orthanc/DICOMweb metadata retrieval, and a Fast Healthcare Interoperability Resources (FHIR) publication view tested covered software routes. At the selected-series level, a covered standard UDI-related signal was observed in 0/12 IDC series and 0/1 TCIA series. Within scanned records, manufacturer/model appeared in 442/442 IDC and 49/49 TCIA records; serial number appeared in 246/442 IDC and 0/49 TCIA records. Unique Device Identifier, UDI Sequence, and contributing-equipment UDI signal were 0/442 in IDC and 0/49 in TCIA. Synthetic controls detected covered UDI patterns; Orthanc/FHIR local round-trips passed. Basic equipment descriptors were available in selected public archive series, but no covered standard UDI-related signal was observed in the covered standard fields and sequence paths. The result is descriptive and may reflect de-identification, export, curation, or acquisition-era effects; it is not clinical, regulatory, real-device, or deployment validation.

PMID:
42527787
Bibliographic data and abstract were imported from PubMed on 30 Jul 2026.

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