# K140399: Ebm Ido Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Ebm Technologies USA, LLC
- Decided: Sep 18, 2014 after 212 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K202292: UDE (2020), 0 descendants of its own
- K162285: EBM iDO Viewer 1.2.1 (2017), 0 descendants of its own

## Indications for use
EBM iDO Viewer software is intended to display images from CT/MR for the trained physician ‘s diagnosis or referring purpose. EBM iDO Viewer provides wireless and portable access to medical images. It is not intended to be used as, or to replace, a full diagnostic workstation or system and should be used only when there is no access to a workstation. This device is not to be used for mammography.

Source page: https://510kreport.com/device/K140399
Methodology: https://510kreport.com/methodology