# CDRH-2024-122752-Add-on SenoBright HD with Nira IQ suite software for GE Pristina FFDM/DBT System.

Canonical: https://abierto.us/opportunities/fdarfqcdrh2024122752

- Solicitation number: FDA-RFQ-CDRH-2024-122752
- Notice type: Combined synopsis and solicitation (first published as sources sought)
- Status: Closed. Deadline was May 5, 2024 at 12:00 PM EDT
- Department: Department of Health and Human Services
- Agency: Food and Drug Administration
- Contracting office: FDA Office of Acq Grant SVCS (75F401)
- NAICS: 334516 Analytical Laboratory Instrument Manufacturing
- Product or service code: AJ11 General Science And Technology R&D Services; General Science And Technology; Basic Research
- Place of performance: Silver Spring, Maryland
- County: Montgomery County (FIPS 24031). https://abierto.us/counties/montgomery-county-md-24031
- City: Silver Spring. https://abierto.us/cities/silver-spring-md-2472450
- First posted: April 18, 2024
- Last posted: April 22, 2024
- SAM.gov: https://sam.gov/workspace/contract/opp/6753d14f1e224968b08cb5a85675c58c/view

## Description

The U. S. Food & Drug Administration, (FDA) Office of Acquisition and Grants Services (OAGS) has a requirement to procure a CDRH-2024-122752-Add-on SenoBright HD with Nira IQ suite software for GE Pristina FFDM/DBT System under Solicitation: FDA-RFQ-CDRH-2024-122752.

The objective of the requirement is to procure the contrast-enhanced mammography software (SenoBright HD with Nira IQ suite) for the GE Senographe Pristina mammography system that will allow FDA researchers to develop and compare new methods for testing performance for this mode of mammography system. The end result of this requirement if the contract is successful will be the development of new approaches for objectively assessing image quality of contrast mammography systems.

These new testing methods could potentially reduce the burden of sponsors that submit new technology to the FDA for approval and accelerate the introduction of new contrast mammography breast imaging products to the general public. New testing methods will be published as an OSEL regulatory science tool. See the attached RFQ for a response.

## Publications

- April 18, 2024: Sources sought, due April 10, 2024 at 12:00 PM EDT. Notice 440a87ba8ea648199c61b48956f42ce3. https://sam.gov/workspace/contract/opp/440a87ba8ea648199c61b48956f42ce3/view
- April 22, 2024: Combined synopsis and solicitation, due May 5, 2024 at 12:00 PM EDT. Notice 6753d14f1e224968b08cb5a85675c58c. https://sam.gov/workspace/contract/opp/6753d14f1e224968b08cb5a85675c58c/view

## Points of contact

- Emmanuel T. Mbah, Emmanuel.mbah@fda.hhs.gov, 2404027598

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Source: SAM.gov Contract Opportunities bulk extract. Confirm deadlines on SAM.gov before responding. Cite https://abierto.us/opportunities/fdarfqcdrh2024122752.