# K213405: MINE ALNU (Model: Mine 2.1)

- Pathway: 510(k) (Traditional)
- Applicant: Hdt Co., Ltd.
- Decided: Jul 10, 2022 after 264 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)
- K212144: Remex KA6, Remedi Co., Ltd. (2021) Summary page 5.

## Indications for use
Mine 2.1 is a portable medical diagnostic-purpose X-ray generator that can be hand-held. The device uses an adjustable tube voltage and a fixed tube current for producing diagnostic x-ray images of extremities for both adults and pediatrics. It is intended to be used by a qualified and trained clinician on all patients. It is not intended to replace a radiographic system with variable tube current and voltage (kVp) which may be required for full optimization of image quality and radiation exposure for different exam types.

Source page: https://510kreport.com/device/K213405
Methodology: https://510kreport.com/methodology