# K182537: RADMAX Digital Imaging Software

- Pathway: 510(k) (Traditional)
- Applicant: DRGEM Corporation
- Decided: Mar 8, 2019 after 175 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K896095 (1990). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123650: Arix Rad Acquisition Console, Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. (2013) Summary page 4.

## Indications for use
The RADMAX Digital Imaging Software, used together with a digital X-ray detector is a digital X-ray image processing system designed for acquiring images and processing acquired images. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, and image processing. The RADMAX Digital Imaging Software, is not intended for the acquisition of mammographic image data. The X-ray generator is not part of the RADMAX Digital Imaging Software, device. If the X-ray generator does not allow interfacing with external software the RADMAX Digital Imaging Software device cannot be interfaced with X-ray Generator. However, when using third-party generator, use the AED function to acquire the image by sensing the X-ray photon. When using the DRGEM Corporation, generator (models GXR, GXR-C, GXR-U), the RADMAX Digital Imaging Software can only select or change values of X-ray exposure parameters (kVP, mA, Time, or kVP, mAs or kVP, mA or density).

Source page: https://510kreport.com/device/K182537
Methodology: https://510kreport.com/methodology