These devices are limited by federal law to investigational use for indications not in the “Indications for Use” statement for a specific system type. Under federal law, these devices should only be used for the functions set forth in the “Indications for Use” statements.
Warning
Read the full prescribing information on the contrast media label before use of contrast media. Use contrast media only in accordance with Indications and Usage as described in full prescribing information.