The Therak 25 and the Therak 20 and the 510 K Procedure

Harkenster: We've seen this happen as a loophole with the car industry. It's like a slight refinement of an existing thing that you've already passed. Or maybe an airplane. So subsequently to the Therak 25, there's been other device scandals which have occurred in orthopedics. And also sort of transvaginal mesh implants is the other big medical scandal so these are sort of implantable meshes and they were originally developed for hernias.