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# FDA Guide on Pediatric Info in X-ray 510(k)s
- URL: https://www.fdaweb.com/fda-guide-on-pediatric-info-in-x-ray-510-k-s/
- Published: 2017-11-28T12:00:00.000Z
- Updated: 2026-09-14T23:03:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140216

*Federal Register* notice: FDA has made available a guidance entitled “Pediatric Information for X-ray Imaging Device Premarket Notifications.” The document encourages the inclusion of pediatric indications for use for x-ray 510(k) submissions, and it provides recommendations on information to support such indications. Both new devices and modifications of existing x-ray imaging devices that require a 510(k) are included within the scope of the guidance. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-11-28/pdf/2017-25632.pdf?ref=fdaweb.com).