# K973712: Minxray HF100H High Frequency Diagnostic X-Ray Unit

- Pathway: 510(k) (Traditional)
- Applicant: Minxray, Inc.
- Decided: Dec 12, 1997 after 74 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: 1 generation back to K945707 (1995). 1 ancestor in all.
18 later devices descend from it; 2 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)
- K945707: Minxray HF80H High Frequency Diagnostic X-Ray Unit, Minxray, Inc. (1995) Summary page 1.

## Most influential descendants
- K052721: Minxray, Model HF100H+ (2005), 16 descendants of its own
- 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

## Indications for use
The MinXray HF100H will be initially marketed for portable and mobile general purpose diagnostic medical radiography. Because of its compact size and high output to weight ratio, we anticipate that the initial uses will be in field, home care, and nursing home diagnostic radiographic applicatons. These uses are typical of the predicate device, the MinXray HF80H. We believe that the safety and effectiveness of the two models are substantially equivalent. Experience in the market with the HF100H may make us aware of other possible applications. This unit may be eventually married with stands for permanent or semi-permanent installation for intra-operative use, hand and/or foot radiography, or other medical diagnostic applications. MinXray will make some stands available for use the HF100H. Other manufacturers may make stands compatible with various portable X-ray units, and we anticipate that some end users will purchase a MinXray HF100H to be used with some other stand of their choice.

Source page: https://510kreport.com/device/K973712
Methodology: https://510kreport.com/methodology