GeneralDevices & AI clearances

FDA Clears Candelis ImageGrid StreamVue

U.S. FDA1w ago

FDA cleared Candelis' ImageGrid StreamVue via 510(k) (product code LLZ) for radiology image management.

  • The 510(k) clearance covers the ImageGrid StreamVue device (product code LLZ).
  • Candelis, Inc. is the applicant; the FDA Radiology committee reviewed the submission.
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