# K011311: Urologic

- Pathway: 510(k) (Traditional)
- Applicant: Pck Electronic Industry and Trade Co, Ltd.
- Decided: Jul 10, 2001 after 71 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- 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: 1 generation back to K940295 (1994). 2 ancestors in all.
47 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940295: Uroview Model 2600, Ge Dec Medical Systems (1994) Summary page 2.
- K943581: Hydradjust IV Urological Table, Mallinckrodt Group, Inc. (1995) Summary page 2.

## Most influential descendants
- K042236: G-SCAN (2004), 45 descendants of its own
- K060956: G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan XQ-Models-9800010011/9800010005,9800010009/9800010004 (2006), 43 descendants of its own
- K063207: S-Scan Mri System (2006), 34 descendants of its own
- K061429: Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera (2006), 32 descendants of its own
- K080968: S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera (2008), 24 descendants of its own

## Indications for use
UROlogic is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures

Source page: https://510kreport.com/device/K011311
Methodology: https://510kreport.com/methodology