RFI_CDRH-2026-133668_Flat_Panel_Detector.docx
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- Flat Panel Detector
- Solicitation number
- CDRH-2026-123668
About this file
This is a Request for Information (RFI) issued by the FDA's Center for Devices and Radiological Health (CDRH) regarding flat panel detector technology. The RFI seeks information from potential contractors to better understand the market capabilities, technical specifications, and commercial availability of flat panel detectors that could support FDA's operational needs. The document is part of a pre-solicitation phase for a potential future procurement (Solicitation Number CDRH-2026-123668).
The RFI requests detailed responses about flat panel detector products, including technical capabilities, performance specifications, cost estimates, delivery timelines, and company qualifications. Respondents are expected to provide information on detector configurations, resolution capabilities, image quality characteristics, and any regulatory certifications or approvals. The information gathered through this RFI will inform the FDA's requirements development and facilitate a more efficient competitive procurement process. No binding commitments or awards result from RFI responses, and the FDA indicates that it may or may not issue a subsequent formal solicitation based on the market research findings. Responses to this RFI are non-binding, and the FDA reserves the right to use any information provided for future procurement planning purposes.
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REQUEST FOR INFORMATION (RFI)
Large-Area 2D X-Ray Flat Panel Detector RFI Number: CDRH-2026-133668 Issuing Office: Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) NAICS Code: 334510 – Electromedical and Electrotherapeutic Apparatus Manufacturing Issue Date: May 15, 2026 Response Deadline: May 21, 2026, 10:00 AM Eastern Time Point of Contact: Freshta Javid Email: Freshta.Javid@fda.hhs.gov
1. PURPOSE
The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) is issuing this Request for Information (RFI) as part of market research conducted in accordance with FAR Part 10. This RFI is issued solely for informational and planning purposes. It does not constitute a solicitation, a request for proposal, or an obligation on the part of the Government to acquire any products or services. No award will be made from this RFI. Responses will not be returned and will not be considered as proposals or quotations.
2. BACKGROUND
CDRH requires one (1) large-area 2D X-ray flat panel detector to support laboratory cone-beam CT (CBCT) and fluoroscopy imaging. The detector will be used for human-sized phantom development, testing, and validation of imaging evaluation methods. The Government is conducting market research to identify sources capable of providing a detector meeting or exceeding the minimum performance specifications listed below.
3. MINIMUM TECHNICAL REQUIREMENTS
Vendors are requested to identify whether their product meets or exceeds the following minimum specifications:
| Parameter |
| Minimum Requirement |
| Active Imaging Area |
| ≥ 42.7 cm × 42.7 cm |
| Pixel Pitch |
| ≤ 170 µm |
| MTF |
| ≥ 50% at 1 lp/mm (full-resolution mode) |
| DQE |
| ≥ 70% at 0 lp/mm |
| Lag |
| ≤ 3% (first frame) |
| Energy Range |
| 40–150 kVp (or wider) |
| Fill Factor |
| ≥ 60% |
| Fluoroscopy Mode |
| ≥ 25 fps at ~3×3 binning, large FOV |
| Fluoro Zoom Mode |
| ≥ 30 fps at ~2×2 binning (if offered) |
| CBCT Projection Mode |
| ≥ 40 fps at ~4×4 binning |
| Radiography (Full Res) |
| ≥ 4 fps |
| Cooling |
| Air cooling only (no liquid cooling) |
| Operating Temperature |
| 19–49°C (or wider) |
| Relative Humidity |
| 10–90% non-condensing (or wider) |
| Radiation Tolerance |
| ≥ 2,000 Gy (active area) |
| Weight |
| ≤ 15 kg |
| Warranty |
| Minimum 1 year |
| Technical Support |
| Minimum 1 year (remote support required) |
4. REQUESTED INFORMATION
Interested vendors are requested to provide the following information in their response:
1. Company name, address, CAGE code, and Unique Entity ID (UEI)
1. Business size under NAICS 334510 (small business, large business, or socioeconomic category if applicable)
1. Product name, model number, and manufacturer
1. Confirmation that the product meets or exceeds each minimum requirement listed in Section 3 (a simple table or checklist format is acceptable)
1. Estimated unit price range (budgetary, not a binding quote)
1. Estimated delivery lead time after award
1. Any standard warranty or support options available
1. Any exceptions or deviations from the minimum requirements
5. INSTRUCTIONS FOR RESPONDING
Responses to this RFI are voluntary. There is no cost to the Government for information provided in response to this RFI. Respondents will not be reimbursed for any costs associated with preparing a response.
All responses must be submitted via email to Freshta Javid at Freshta.Javid@fda.hhs.gov no later than May 22, 2026, 5:00 PM Eastern Time. Please reference RFI Number CDRH-2026-133668 in the subject line of your email.
Responses should be concise and limited to 5 pages or less.
6. DISCLAIMER
This RFI is issued for market research purposes only and does not commit the Government to issue a solicitation, make an award, or pay any costs incurred in the preparation of a response. The Government reserves the right to cancel this RFI at any time without obligation. Proprietary information should be clearly marked as such; however, the Government assumes no liability for the use or disclosure of such information.
Questions regarding this RFI may be directed to:
Freshta Javid Food and Drug Administration Center for Devices and Radiological Health (CDRH) Email: Freshta.Javid@fda.hhs.gov
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