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# 510(k) Guidances for 2 Ultrasound-type Devices Published
- URL: https://www.fdaweb.com/510-k-guidances-for-2-ultrasound-type-devices-published/
- Published: 2023-02-21T12:00:00.000Z
- Updated: 2026-09-14T18:16:39.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153821

FDA has published guidances relating to marketing clearances of diagnostic ultrasounds and 510(k) submissions for ultrasonic diathermy devices. The first guidance, *Marketing Clearance of Diagnostic Ultrasound Systems and Transducers*, gives detailed recommendations for 510(k) submissions for diagnostic ultrasound systems and transducers. FDA says that 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 the agency does not intend to enforce the requirements for a new 510(k).

The second guidance, *Premarket Notification \[510(k)\] Submissions for Ultrasonic Diathermy Devices*, has recommendations for submissions for these devices, which are also known as physiotherapy devices. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-clarification-and-premarket-notification-510k-submissions-ultrasonic-diathermy-devices?ref=fdaweb.com) includes recommendations on using certain International Electrotechnical Commission standards in generating information that can support 510(k) submissions for these devices. It also supplements other FDA documents regarding the specific content requirements and recommendations of a 510(k) submission.