SAM #CDRH-2026-123668

FDA RFI for Large-Area 2D X-Ray Flat Panel Detector

The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) is seeking information from industry regarding a large-area 2D X-ray flat panel detector for laboratory imaging applications. - Government Buyer: - Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) - Product Requested: - Large-area 2D X-ray flat panel detector - Quantity: 1 unit - Intended for laboratory cone-beam CT and fluoroscopy imaging - Minimum technical requirements: - Active imaging area: 42.7 cm - Pixel pitch: 170 µm - Modulation Transfer Function (MTF): 50% at 1 lp/mm - Detective Quantum Efficiency (DQE): 70% at 0 lp/mm - Lag: 3% - Energy range: 40-150 kVp - Fill factor: 60% - Imaging modes: fluoroscopy and CBCT projection - Air cooling - Operating temperature: 19-49°C - Relative humidity: 10-90% (non-condensing) - Radiation tolerance: 2000 Gy - Weight: 15 kg - Minimum 1-year warranty and technical support - Vendor Response Requirements: - Provide product details and compliance with specifications - Include pricing, delivery lead time, and warranty/support information - No specific OEMs or part numbers are mentioned in the solicitation - Notable Requirements: - Detector must meet all listed technical specifications - Warranty and technical support for at least one year - Air cooling and high radiation tolerance are required

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