|Trade Name||LUMA CERVICAL IMAGING SYSTEM|
|Classification Name||sensor,electro-optical(for cervical cancer)|
|Generic Name||optical detection system (ods)|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Modifications to the incoming camera inspection test, test software used to assemble the luma system and the final test software used during burn-in.