||light source system, diagnostic endoscopic|
||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.
||System includes a PPD light source, specific PDD telescopes for cystoscopy), camera system (PDD camera control unit, and PDD camera heads) fluid light cable, and PC based software communication program
||1. excitation and emission filters in the PDD telescopes and PDD camera heads limit light to the blue portion of the visible spectrum The combination of these 2 filters in conjunction with the photo- fluorescent drug Hexvix? enables visualization of carcinoma in situ (CIS) as a red fluorescent image against normal tissue that appears blue.
Office of Device Evaluation
Division of Reproductive, Gastro-Renal, and Urological Devices
Urology and Lithotripsy Devices Branch (ULDB)
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
|Third Party Review
||Not Third Party Eligible