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Q:
Why does MapCALC not have a 510k?
A:
Like other MU calculation products, MapCALC is an FDA Class I device, which does not require a 510k. A 510k is issued by the US Food and Drug Administration (FDA) to products (including Class II, IIb, and III medical devices) that meet FDA criteria. A 510k is formal FDA clearance to market a specific product for a specific intended use, and contrary to many misleading marketing statements no product is "FDA Approved". Sun Nuclear does market Class II medical devices such as PROFILER 2 and PC Electrometer, and these devices have the required 510k.

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