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# Diagnostic Ultrasound, Transducer Marketing Guidance
- URL: https://www.fdaweb.com/diagnostic-ultrasound-transducer-marketing-guidance/
- Published: 2019-06-26T12:00:00.000Z
- Updated: 2026-09-15T01:35:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144427

FDA has published a guidance, *Marketing Clearance of Diagnostic Ultrasound Systems and Transducers*, with recommendations for manufacturers seeking marketing clearance for diagnostic ultrasound systems and transducers. In addition to outlining regulatory approaches for certain diagnostic ultrasound devices, the [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-clearance-diagnostic-ultrasound-systems-and-transducers?ref=fdaweb.com) describes the types of modifications to a diagnostic ultrasound device for which FDA does not intend to enforce the requirement for a new 510(k). As before, FDA says, manufacturers who submit a 510(k) and receive marketing clearance will continue to be exempt from the Electronic Product Radiation Control reporting requirements for diagnostic ultrasound devices.