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# Petition Seeks Action Against MRI Accessories
- URL: https://www.fdaweb.com/petition-seeks-action-against-mri-accessories/
- Published: 2016-10-10T12:00:00.000Z
- Updated: 2026-09-14T21:38:27.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137033

A citizen petition from the law firm Wood, Herron & Evans urges FDA to detain Magnacoustics’s MagnaTouch MRI Music System, Genesis Ultra MRI Music System and MagnAlarm because they are not cleared by the agency under a 510(k). The [petition ](https://www.regulations.gov/document?D=FDA-2016-P-3195-0001&ref=fdaweb.com)says the devices are “clearly accessories to magnetic resonance diagnostic devices and remote medication management systems within the meaning of 21 CFR § 892.1000\. Consequently, in the absence of device and establishment registration and pre-market notification as required under the Act, the MagnaTouch MRI Music System, Genesis Ultra MRI Music System and MagnAlarmdevices are misbranded.” Based on research by the law firm, Magnacoustics has not successfully submitted evidence of substantial equivalence to FDA, which includes compliance with recognized consensus standards for such.