# K121838: Liebel-Flarsheim Direct Digital Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Liebel-Flarsheim
- Decided: Jul 11, 2012 after 19 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 2 (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). 72 ancestors in all.
No later device cites it as a predicate yet.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943581: Hydradjust IV Urological Table, Mallinckrodt Group, Inc. (1995) Summary page 1.
- K101491: Uroskop Omnia, Siemens Medical Solutions USA, Inc. (2010) Summary page 1.
- K103416: Nexus DRF Digital X-Ray Imaging System, Infimed, Inc. (2011) Summary page 1.

## Recalls of this device
- Mar 11, 2021 · Class II · Z-1992-2021: Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than ¿ 35
- Feb 27, 2017 · Class II · Z-2834-2018: Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than

## Indications for use
The Liebel-Flarsheim Direct Digital Imaging System is a solid state detector X-ray system that facilitates digital radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation and a flat imaging table primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/surgery. The system inky be used for urological, gastroenterological, and gynecological treatment, planning and diagnostic procedures. It is intended to replace fluoroscopic images formerly obtained through image intensifier technology. Not intended for mammography applications.

Source page: https://510kreport.com/device/K121838
Methodology: https://510kreport.com/methodology