The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) is seeking information about large-area 2D X-ray flat panel detectors. The detector will be used for laboratory cone-beam CT (CBCT) and fluoroscopy imaging, and it must meet or exceed certain minimum performance specifications. These specifications include an active imaging area of at least 42.7 cm × 42.7 cm, a pixel pitch of 170 µm or less, and a minimum frame rate of 25 fps in fluoroscopy mode. Interested vendors are requested to provide information about their products, including whether they meet the minimum requirements, estimated unit price range, and estimated delivery lead time.
Some key points to consider are:
• The detector must have an active imaging area of at least 42.7 cm × 42.7 cm
• The pixel pitch must be 170 µm or less
• The detector must be able to operate in fluoroscopy mode at a minimum frame rate of 25 fps
• The detector must be able to operate in CBCT projection mode at a minimum frame rate of 40 fps
• The detector must have a minimum warranty of 1 year and technical support for at least 1 year
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