# K153119: Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System,

- Pathway: 510(k) (Traditional)
- Applicant: Summit Industries, LLC
- Decided: Mar 14, 2016 after 137 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K801623 (1980). 65 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121513: Multix Fusion, Siemens Medical Solution (2012) Summary page 4.

## Most influential descendants
- K183541: ProRad 2FC and ProRad 3NC Stationary Radiographic Systems (2019), 0 descendants of its own
- K173823: Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System (2018), 0 descendants of its own

## Indications for use
These radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, angiography, interventional, or fluoroscopy use.

Source page: https://510kreport.com/device/K153119
Methodology: https://510kreport.com/methodology