# K182639: MOBILETT Elara Max

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Mar 15, 2019 after 172 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K801623 (1980). 67 ancestors in all.
No later device cites it as a predicate yet.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111912: Mobilett Mira, Siemens Medical Solutions USA, Inc. (2011) Summary page 5.

## Indications for use
MOBILETT Elara Max is a mobile device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. MOBILETT Elara Max enables radio-graphic exposures of the whole body and may be used on pediatric, adult and bariatric patients. It can also be used for emergency applications. MOBILETT Elara Max is not indicated for mammographic imaging.

Source page: https://510kreport.com/device/K182639
Methodology: https://510kreport.com/methodology