# K241996: ULTRA 1040

- Pathway: 510(k) (Traditional)
- Applicant: Ecoray Co., Ltd.
- Decided: Apr 18, 2025 after 283 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: 4 generations back to K040046 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200637: SR-8100 Portable X-ray Unit, Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) (2020) Summary page 6.

## Indications for use
The ULTRA 1040 Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the patient’s extremities. This device is not intended for mammography.

Source page: https://510kreport.com/device/K241996
Methodology: https://510kreport.com/methodology