# K052721: Minxray, Model HF100H+

- Pathway: 510(k) (Special)
- Applicant: Minxray, Inc.
- Decided: Oct 27, 2005 after 28 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 K945707 (1995). 3 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973712: Minxray HF100H High Frequency Diagnostic X-Ray Unit, Minxray, Inc. (1997) Summary page 1.
- K040046: Minxray, Model HF120/60H Powerplus, Minxray, Inc. (2004) Summary page 1.

## Most influential descendants
- K140723: Nomad MD 75K V Handheld X-Ray System (2014), 8 descendants of its own
- K203658: Micro C Medical Imaging System, M01 (2021), 2 descendants of its own
- K193535: EZER, Portable X-ray System (2020), 2 descendants of its own
- K143494: ADX6000 Portable X-Ray System; iRayA6 (2015), 2 descendants of its own
- K211473: Micro C Medical Imaging System, M01 (2021), 1 descendant of its own

## Indications for use
The MinXray HF100H+TM is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.

Source page: https://510kreport.com/device/K052721
Methodology: https://510kreport.com/methodology