OAY
- Product code
- OAY
- Device name
- Light Source System, Diagnostic Endoscopic
- Device class
- Class 3
- Medical specialty
- Unknown
- Marketing pathway
- PMA
FDA classification definition
A fluorescence system intended for use as an adjunct to white light cystoscopy when used in combination with a photosensitizer for the detection of bladder cancer. Patients with known or suspected bladder cancer and/or recurrence of bladder cancer, in patients undergoing diagnostic testing for bladder cancer by cystoscopy or positive urine cytology or who present with hematuria and/or a positive urine cytology test.
Official FDA classification page: OAY
Classification and pathway per current FDA publications. Data from openFDA (CC0).