About this document
Us Fda K253779 by ryder.kossak is a document available to read on EtoBox.
The FDA has determined that the SIGNA™ Sprint Select device is substantially equivalent to legally marketed predicate devices and can be marketed under the 510(k) premarket notification process. This whole-body magnetic resonance scanner is designed for high-resolution imaging and is indicated for various diagnostic imaging applications. The device features advanced technology, including superconducting magnets and AI capabilities, while maintaining compliance with regulatory standards and requirements.
- Author
- ryder.kossak
- Language
- EN