Class III via 510k and not PMA. Device shows real time 3D images updated at an impressive rate.
Radiation is considered high enough to fall under class 3. Couple this with software that currently isn't in use and you have enough criteria for "not substantially different technology" to be tested.
• Class III devices are subject to general controls, but are distinguished from class I and II devices because class III devices are those (1) for which insufficient information exists to determine whether general and special controls are sufficient to provide a reasonable assurance of the safety and effectiveness of the device and (2) that support or sustain human life or are of substantial importance in preventing impairment of human health, or that present a potential unreasonable risk of illness or injury.
Since no one is willing to read the review I posted....
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