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510(k) Data Aggregation
(119 days)
ACCESS RADIOLOGY CORP.
The ACCESS Radiology Teleradiology Image Acquisition and Distribution System with Picture and Archive Communications Systems products are intended to be used by healthcare professionals as a radiological image acquisition, storage, and routing system for remote acquisition and transmission of diagnostic images.
The ACCESS Radiology Teleradiology Image Acquisition and Distribution System with Picture and Archive Communications Systems
My apologies, but the provided text does not contain the specific information required to complete your request. The document is an FDA 510(k) clearance letter for a teleradiology system, detailing its substantial equivalence to previously marketed devices and its indications for use.
It does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, number of experts for ground truth, or adjudication methods.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used or details about training sets.
Therefore, I cannot extract the requested information from the given text.
Ask a specific question about this device
(170 days)
ACCESS RADIOLOGY CORP.
Ask a specific question about this device
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