Description
The FDA’s Center for Devices and Radiological Health (CDRH) is seeking a single, fully integrated endoscopy system—including video processor, colonoscope, 4K medical display, and cart—to support bench‑testing of endoscopic devices. The system must be FDA‑cleared (510(k)) for all components, support multiple imaging modes (white light, NBI, color enhancement), provide specific video output formats, and meet detailed technical specifications for optics, illumination, and ergonomics. Delivery is required within six weeks of award to the FDA facility in Silver Spring, MD, with a one‑year warranty covering parts, labor, and shipping. Quotes must be submitted electronically by September 16, 2026, and must be firm‑fixed‑price, valid for at least 60 days.
• One‑off purchase of a complete, FDA‑cleared endoscopy system (video processor, colonoscope, 4K display, cart)
• Must meet detailed performance specs (LED light source, ≥2 NBI modes, ≥2 digital color‑enhancement modes, 12G/3G/HD‑SDI outputs)
• Colonoscope: forward‑viewing, ≥170° FOV, ≤12.8 mm tip, ≥3.7 mm instrument channel, water nozzle, wide angulation
• Display: ≥32‑inch, 4K resolution, multiple input ports (SDI, DP, HDMI, DVI)
• Delivery within 6 weeks to FDA, Silver Spring, MD; 1‑year warranty inclusive of parts, labor, travel, shipping
• Firm‑fixed‑price quote, submitted by email only; questions due 9/14/2026, offer deadline 9/16/2026
• Award will be based on Lowest Priced Technically Acceptable (LPTA) criteria