# K974355: Interventional Mobile Digital Imaging System (Herein Called Imdis)

- Pathway: 510(k) (Traditional)
- Applicant: Ge Dec Medical Systems
- Decided: Feb 17, 1998 after 90 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- 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
No predicates in its family tree.
43 later devices descend from it; 2 cite it directly.
1 of 44 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) OEC Medical Systems - SERIES 9600® Mobile Digital Imaging System: named in the summary without a submission number
- (no number) Philips Medical Systems - BV 300 Series Mobile C-arm System: named in the summary without a submission number

## Most influential descendants
- K013484: Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging System, Niobe Electrophysiology Mapping Cath (2002), 39 descendants of its own
- K021555: Stereotaxis Niobe Magnetic Navigation System (2003), 35 descendants of its own
- K052480: Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical Steerable Guide Catheter (SGC) and Sheath (2007), 27 descendants of its own
- K073225: Sensei Catheter Control System (2008), 24 descendants of its own
- K090365: Hansen Medical Artisan S Control Catheter (2009), 22 descendants of its own

## Recalls of this device
- Jul 22, 2016 · Class II · Z-2629-2016: A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed.

## Indications for use
The IMDIS is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician’s discretion.

Source page: https://510kreport.com/device/K974355
Methodology: https://510kreport.com/methodology