Goldenpig, 510k. Is the application that covers tests and devices. RHR run software that analyses data from an MRI scan to give accurate Liver Iron Overload and Liver Fibrosis reading. They used a 510k application to get this test approved.
510k approvals are quick to get approed, once the FDA have all the data they are required to give a ruling within 90 days.So generally the whole process can be completed in about 6 months.
ACG has a new type of Blood Pressure test they went through 510k. So another good place to have a quick read. Generally for tests and devices.
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