# K143537: Sirius Starmobile tiara

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Mar 6, 2015 after 81 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: 2 generations back to K041763 (2004). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120062: DRX-Revolution Mobile X-Ray System, Carestream Health, Inc. (2012) Summary page 4.

## Most influential descendants
- K170858: FDR Aqro (DR-XD 1000) (2017), 0 descendants of its own

## Indications for use
The Mobile X-ray Unit Sirius Starmobile tiara is a general radiography system and is composed of the X-ray high voltage generator, X-ray tube, support unit, and digital radiograph device (DR-ID 800) made by Fujifilm Corporation. This device is designed for pediatric and adult patients. It is intended for use in general radiography of the head, body, or extremities including pediatric exams. The device output can provide an aid to diagnosis when used by a qualified physician.

Source page: https://510kreport.com/device/K143537
Methodology: https://510kreport.com/methodology