SAM #CDHR-2026-133666

FDA Seeks Adaptive Optics Retinal Imaging System for Ophthalmic Research

The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL), is seeking sources for a high-resolution Adaptive Optics (AO) Retinal Imaging System to support ophthalmic research and regulatory science. - Government Buyer: - Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL), Division of Biomedical Physics (DBP) - OEMs and Vendors Mentioned: - Imagine Eyes - Canon Inc. - EarlySight - Physical Sciences Inc. - Robotrak Technologies - Products/Services Requested: - Adaptive Optics (AO) Retinal Imaging System (1 unit) - High-resolution ophthalmic imaging device with hardware and software - Key features: pupillary reflectance imaging, infrared LED and SLD light sources (750-890 nm), lateral resolution 2-3 microns, pixel pitch 1 micron, focusing range 300 microns, cellular view image field angle >6.5 x 6.5 degrees, fundus overview 30 x 30 degrees, minimum pupil diameter 4 mm, refractive error adjustment +15 D to -15 D, acquisition time <3 seconds, internal/external fixation targets, simultaneous live widefield and cellular-level imaging, pupil alignment feedback, and follow-up image comparison - Physical requirements: input voltage 100-240 V, max power 450 W, dimensions <=65cm x 65cm x 65cm, weight <=60 kg - Delivery, installation, and setup at FDA White Oak Campus - User manuals and operator training included - One-year full warranty after delivery - Unique or Notable Requirements: - System must support both widefield and cellular-level retinal imaging - Must include delivery, installation, operator training, and warranty - Supports collaborative research with NEI and Johns Hopkins - All packaging and marking must meet government specifications

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