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# Quantitative Imaging Assessment in Premarket Submissions
- URL: https://www.fdaweb.com/quantitative-imaging-assessment-in-premarket-submissions/
- Published: 2022-06-15T12:00:00.000Z
- Updated: 2026-09-14T17:48:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152081

FDA has published a guidance, *Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions*, with recommendations for manufacturers about information that should be in premarket submissions for radiological devices that include quantitative imaging functions. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/technical-performance-assessment-quantitative-imaging-radiological-device-premarket-submissions?ref=fdaweb.com) clarifies that, in general, manufacturers preparing premarket submissions (PMA, HDE, 510(k), IDE, and de novo requests) for radiological devices that include quantitative imaging functions should provide performance specifications for the quantitative imaging functions, supporting data to demonstrate that the quantitative imaging functions meet those performance specifications, and sufficient information for the end user to obtain, understand, and interpret the values provided by the quantitative imaging function.