# K161019: Uroview FD

- Pathway: 510(k) (Traditional)
- Applicant: Pausch Medical GmbH
- Decided: Aug 17, 2016 after 127 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K801623 (1980). 58 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101491: Uroskop Omnia, Siemens Medical Solutions USA, Inc. (2010) Summary page 4.

## Most influential descendants
- K200965: XR-MX/1000 (2020), 0 descendants of its own
- K180651: Uroview FD II (2018), 0 descendants of its own

## Recalls of this device
- Mar 14, 2017 · Class II · Z-2152-2017: During patient interventions with the urology table the radiation is activated with a footswitch connected to the table. This footswitch is actively involved in the safety circuit of the urological ta

## Indications for use
The Uroview FD 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/K161019
Methodology: https://510kreport.com/methodology