# K162285: EBM iDO Viewer 1.2.1

- Pathway: 510(k) (Traditional)
- Applicant: Ebm Technologies Incorporated
- Decided: Jan 27, 2017 after 165 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
Longest line of descent: 1 generation back to K140399 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140399: Ebm Ido Viewer, Ebm Technologies USA, LLC (2014) Summary page 4.

## Indications for use
EBM iDO Viewer 1.2.1 software is intended to display images from CT, MR , CR, US, XA and SC for the trained physician ‘s diagnosis or referring purpose. EBM iDO Viewer 1.2.1 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 diagnosis.

Source page: https://510kreport.com/device/K162285
Methodology: https://510kreport.com/methodology