Amendment One PHOTON COUNTING CdTe COUNTING X-RAY DETECTOR

Amendment One: PROPOSAL DUE: All Volumes for the quotes are due, electronically through email to [email protected] no later than May 29, 2020, 10:00 a.m. Eastern Standard Time. Ensure the email subject line annotates the solicitation number and description: 75F40120Q00049_0001 PHOTON COUNTING CdTe COUNTING X-RAY DETECTOR ****************************************************************************************************** This is a combined synopsis/solicitation for commercial supplies prepared in accordance with the Federal Acquisition Regulation (FAR) format Subpart 12.6, as supplemented with additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-06. ***************************BRAND NAME OR EQUAL************************** THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is 75F4012Q00049 and is being issued as a Request for Quote (RFQ). The solicitation is being issued in conjunction with FAR PART 13.106. The associated North American Industry Classification System (NAICS) Code for this solicitation is 334519, Other Measuring and Controlling Device Manufacturing. This requirement is Full and Open Competition with no set-aside. Prospective Offerors are responsible for downloading the solicitation and any amendments. The Government reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing best value and discussions are not necessary. Contract Type-Commercial Supply– Firm Fixed Price The U. S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) requires the following: A. BACKGROUND: The breast imaging laboratory in the Division of Imaging, Diagnostics, and Software Reliability (DIDSR), Office of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health (CDRH) has a custom-built imaging simulator (benchtop system) emulating mammography, digital breast tomosynthesis (DBT), and breast computed tomography (bCT) imaging systems. The FDA previously purchased the XCounter Actaeon FX5 photon counting detector with Cadmium Telluride (CdTe) sensor from XCounter. A custom-built benchtop CT system was vault to accommodate x-ray imaging with this detector. This detector was of size 2 cm x 5 cm. Because of its small size, it was not capable for adequately imaging of the breast. Thus, the FDA requires a larger active area but otherwise compatible photon counting detector x-ray detector to appropriately perform breast imaging. Images of basic physical phantoms, as well as an anthropomorphic breast phantom, will be acquired with both the photon counting detector and a standard energy integrating detector. Performance with this photon counting detector will be compared to that with a conventional energy integrating detector. The detector shall be used for testing and development of material decomposition algorithms to provide new biomarkers for breast lesion analysis. The objective is to purchase a large area Cadmium Telluride photon (CdTe) counting x-ray detector. See attachment for complete COMBINED SYNOPSIS/SOLICITATION