# K200965: XR-MX/1000

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy America, Inc.
- Decided: Dec 29, 2020 after 263 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 4.

## Indications for use
The XR-MX/1000 system is a solid-state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimally invasive urological surgery). The system may be used for urological treatment, planning and diagnostic procedures, including but not limited to: • Querying and retrieving patient information and/or image from other modalities¹ • X-ray examinations of the urogenital area (e.g. cystoscopy, kidney, bladder, ureter, urethra) including KUB², IVP, reflux-cystogram, cystourethrogram, and micturition cystourethrogram combined with uroflow measurements.³ • 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).³ • Percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous nephrostomy)³ • Application of fistula (kidney/bladder)³ • Simple procedures (e.g. urethra, testis, phimosis)³ • Intracorporeal shock wave lithotripsy³ • Uroflow/urodynamics³ • Pediatric radiological and therapeutic applications³ (ages 2 to 22 years) ¹ In conjunction with the StorM-Base 2.0 System (K093603) ² KUB Not indicated for XR-MX/1000 model FD21 ³ In conjunction with the Modulith SLX-F2 system (K072788)

Source page: https://510kreport.com/device/K200965
Methodology: https://510kreport.com/methodology