# K170046: Lilium a-200E

- Pathway: 510(k) (Traditional)
- Applicant: Lilium Otsuka Co., Ltd.
- Decided: Dec 7, 2017 after 336 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K915436 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071217: Bladderscan Bvi 9400 Ultrasound, Verathon Incorporated (2007) Summary page 6.

## Indications for use
Lilium α-200E, using ultrasound, is intended to provide the diagnostic information of the visualized urine dynamics acquired from the volume of the urinary bladder.

Source page: https://510kreport.com/device/K170046
Methodology: https://510kreport.com/methodology