SAM #CDRH-2026-133668

FDA Solicitation for Large-Area 2D X-ray Flat Panel Detector for Laboratory Imaging

The U.S. Food and Drug Administration (FDA) is seeking to procure a large-area 2D X-ray flat panel detector for advanced laboratory imaging applications. - Government Buyer: - U.S. Food and Drug Administration (FDA), Office of Facilities, Engineering and Mission Support - Procurement managed by FDA Office of Acquisition and Grant Services - Products/Services Requested: - One (1) large-area 2D X-ray flat panel detector - Minimum active imaging area: 42.7 cm x 42.7 cm - Pixel pitch: up to 170 microns - Suitable for laboratory cone-beam CT (CBCT) and fluoroscopy imaging - Includes detector, required electronics, interfaces, cables/adapters, documentation, and shipping/handling - Must meet specific image quality, frame rate, X-ray operating range, environmental, mechanical, cooling, and robustness requirements - Minimum 1-year warranty and remote technical support; optional onsite support may be separately priced - OEMs and Vendors: - No specific OEMs or vendors are named in the solicitation - Unique or Notable Requirements: - Detector must support human-sized phantom development and imaging evaluation validation - Delivery must include a complete operational kit - Detailed technical compliance and capability statements required from vendors - Place of Performance and Delivery: - FDA facilities in Silver Spring, Maryland - Contracting office located in Rockville, Maryland

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