CDRH-2024-122752-Add-on SenoBright HD with Nira IQ suite software for GE Pristina FFDM/DBT System.
Closed Solicitation Posted
Not the latest version. See the latest pre-solicitation from .
- Solicitation number
- FDA-RFQ-CDRH-2024-122752
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 334516 Analytical Laboratory Instrument Manufacturing
- PSC
- AJ11 General Science And Technology R&D Services; General Science And Technology; Basic Research
- Place of performance
- Silver Spring, Maryland 20993, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The U.S. Food & Drug Administration (FDA) Office of Acquisition and Grants Services is seeking to procure a CDRH-2024-122752-Add-on SenoBright HD with Nira IQ suite software for the GE Senographe Pristina mammography/tomosynthesis system. The objective is to allow FDA researchers to develop and compare new methods for testing the performance of contrast-enhanced mammography systems. The goal is to develop new approaches for objectively assessing image quality, which could reduce the burden on sponsors submitting new technology to the FDA and accelerate the introduction of new contrast mammography breast imaging products. The solicitation is issued under full and open competition using Simplified Acquisition Procedures, with a Firm Fixed-Price purchase order planned. The period of performance is one year, including a one-year warranty, with delivery and installation of the software to be completed prior to September 30, 2024.
There is no set-aside designation for this opportunity. The main NAICS code is 541715 (Research and Development in the Physical, Engineering, and Life Sciences) and the PSC code is ADP Software. The solicitation does not mention any potential incumbents or current contractors. The award value is not specified, but the objective is to procure the contrast-enhanced mammography software for the GE Senographe Pristina system. The place of performance is Silver Spring, MD 20993, USA.
Notice text
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.
Files
| File | Type | Posted |
|---|---|---|
| FDA-RFQ-CDRH-2024-122752-Add-on SenoBright HD with Nira IQ suite software for GE Pristina FFDMDBT S.docx | DOCX document |
Notice history
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