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# Guide on Diagnostic Ultrasound Systems/Transducers
- URL: https://www.fdaweb.com/guide-on-diagnostic-ultrasound-systems-transducers/
- Published: 2019-06-27T12:00:00.000Z
- Updated: 2026-09-15T01:35:25.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144439

*Federal Register* notice: FDA has made available a final guidance entitled “Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.” The document provides detailed recommendations for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers, and includes guidance describing the types of modifications to a diagnostic ultrasound device for which FDA does not intend to enforce the requirement for a new 510(k). To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-06-27/pdf/2019-13687.pdf?ref=fdaweb.com).