Large Flat Panel Detector (LFPD )

Statement of Work (SOW) / Performance Work Statement (PWS)

To purchase and deliver one (1) large-area 2D X-ray flat panel detector suitable for laboratory cone-beam CT (CBCT) and fluoroscopy imaging to support human-sized phantom development/testing and validation of imaging evaluation methods.

• Geometry/Sampling:

  • Active imaging area: ≥ 42.7 cm × 42.7 cm
  • Pixel pitch: ≤ 170 μm

• Image Quality:

  • MTF: ≥ 50% at 1 lp/mm (full-resolution mode)
  • DQE: ≥ 70% at 0 lp/mm
  • Lag: ≤ 3% (first frame)

• X-ray Operating Range & Performance:

  • Energy compatibility: 40–150 kVp (or wider)
  • Fill factor: ≥ 60%
  • Max entrance dose per frame: ≥ 50 µGy/frame capability

• Frame Rate / Acquisition Modes:

  • Fluoroscopy: ≥ 25 fps (3x3 binning or equivalent)
  • Fluoro zoom: ≥ 30 fps (2x2 binning)
  • CBCT projection: ≥ 40 fps (4x4 binning)
  • Radiography: ≥ 4 fps (full resolution)

• Environmental, Mechanical, Cooling, Robustness:

  • Cooling: Air cooling
  • Operating temperature: 19–49°C (or wider)
  • Relative humidity: 10–90% non-condensing (or wider)
  • Atmospheric pressure: 70–106 kPa (or wider)
  • Radiation tolerance: ≥ 2000 Gy (active area)
  • Weight: ≤ 15 kg

• Delivery to the specified government address.

• Interfaces, Delivery, Warranty, and Support:

  • Complete operational delivery includes detector, required electronics/interface, cables/adapters, and documentation.
  • Shipping and handling to the delivery address.
  • Warranty: Minimum 1-year.
  • Technical support: Minimum 1-year (remote support required; optional onsite support may be offered as a separately priced line item).

• Brand name or equal products may be offered if minimum requirements are met or exceeded.

Sources Sought Notice / Request for Information (RFI)

This notice is issued by the U.S. Food and Drug Administration (FDA) for market research to identify potential sources capable of providing one (1) large-area 2D X-ray flat panel detector for CBCT and fluoroscopy imaging. The detector will support human-sized phantom development, testing, and validation of imaging evaluation methods. This notice does NOT constitute a solicitation or commitment to award a contract.

Vendors must address their ability to provide a detector meeting or exceeding the following minimum requirements:

• Geometry / Sampling:
  • Active imaging area: ≥ 42.7 cm × 42.7 cm
  • Pixel pitch: ≤ 170 µm
• Image Quality:
  • MTF: ≥ 50% at 1 lp/mm
  • DQE: ≥ 70% at 0 lp/mm
  • Lag (first frame): ≤ 3%
• X-Ray Performance:
  • Energy range: 40–150 kVp (or wider)
  • Fill factor: ≥ 60%
  • Max entrance dose/frame: ≥ 50 µGy/frame capability
• Frame Rates:
  • Fluoroscopy mode: ≥ 25 fps
  • CBCT projection mode: ≥ 40 fps
  • Radiography (full-res): ≥ 4 fps
• Environmental / Mechanical:
  • Cooling: Air cooling only
  • Operating temperature: 19–49°C
  • Weight: ≤ 15 kg
• Delivery & Support:
  • Complete operational kit required
  • Minimum 1-year warranty
  • Minimum 1-year remote technical support

Interested parties must submit a capability statement addressing:

• Company Information: Name, address, UEI, CAGE code, POC, business size, SAM.gov registration.

• Technical Capability: Specific product(s) offered, compliance with minimum requirements (provide matrix), deviations, COTS status.

• Delivery and Support: Estimated lead time, warranty, technical support details, teaming arrangements.

• Past Performance (Optional): Description of prior contracts for similar equipment.

• Pricing Information (Optional): Rough Order of Magnitude (ROM) pricing.

• Deadline: May 12, 2026, 4:00 PM Eastern Time

• To: Freshta Javid – Freshta.javid@fda.hhs.gov

• Format: PDF or Microsoft Word (.docx)

• Subject: "Sources Sought Response – Large-Area X-Ray Flat Panel Detector – [Company Name]"

• Page Limit: 10 pages maximum (excluding attachments).

This is for market research only. No award will be made, and no costs will be reimbursed. The FDA will use this information to determine acquisition strategy, including potential small business set-asides.