# K180651: Uroview FD II

- Pathway: 510(k) (Traditional)
- Applicant: Pausch Medical GmbH
- Decided: Apr 12, 2018 after 30 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K801623 (1980). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161019: Uroview FD, Pausch Medical GmbH (2016) Summary page 5.

## Indications for use
The Uroview FD II is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray-diagnostics, endourology and minimal invasive urology/surgery). The system, which includes a radiologic/urologic treatment table, may be used for urological treatment, planning and diagnostic procedures including but not limited to: • Querying and retrieving patient information and /or images from other modalities. • X-ray examination of the urogenital area (e.g. cyctoscopy, kidney, bladder, ureter, urethra) including KUB, IVP, vasovesiculography, reflux-cystogram, cystourethrogram, and micturation cystourethrogram combined with uroflow measurements. • Ultrasound examinations (in conjunction with a stand-alone ultrasound system) of the kidney, bladder, prostate, scrotum. • Endourological interventions (e.g. of the urethra, prostate, bladder, sphincter, ostium, kidney and ureter, catheter placement, penile implant placement, transurethral resection of prostate or bladder, alternative treatment of the BPH and brachytherapy). • Percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous nephrostomy). • Laparoscopy (e.g. cholecystectomy, nephrectomy, lymph node dissection, abdominal testis detection/correction, varicocele). • Application of fistula (kidney/bladder). • Simple procedures (e.g. urethra, testis, phimonis). • Introcorporeal shock wave lithotripsy. • Uroflow/urodynamics. • Pediatric radiological and therapeutic applications.

Source page: https://510kreport.com/device/K180651
Methodology: https://510kreport.com/methodology