# K103554: Metron-CP/MD

- Pathway: 510(k) (Abbreviated)
- Applicant: Eponatech, LLC
- Decided: Dec 20, 2011 after 382 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: 6 generations back to K896095 (1990). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070618: Dicompacs, Model 5, Oehm Und Rehbein GmbH (2007) Summary page 2.
- K003607: Onyx-Rad Telemedicine Pacs, Viztek, Inc. (2001) Summary page 2.

## Indications for use
The EponaTech Metron-CP/MD is a clinical imaging software application for use with DR and CR radiography systems, primarily focused on chiropractic and podiatry use. Metron-CP/MD processes images using state of the art wavelet filtering techniques from various imaging sources and then makes them available to display, edit, review, store, print and distribute using standard PC hardware. Metron-CP/MD stores and organizes the images (radiographs, photographs, etc), and provides many value added features for review and analysis by trained medical practitioners. Advance imaging algorithms produce the best image possible from the imaging hardware. The filters are customizable by the user and organized in Metron-CP/MD'5 searchable database for later review. Metron-CP/MD also supports adding notes, taking accurate physical measurements, and producing other mark-ups to images to aid in analysis over time. Metron-CP/MD also allows the easy creation and editing of formatted, multi-page reports. Metron-CP/MD is currently intended for chiropractic, podiatry use, and general human radiography. It is not intendedfor mammography use. Metron-CP/MD'5 features advance imaging algorithims, calibration and measurement tools, multi-imaging stitching, report generation, and full compliance with voluntary Digital Imaging and Communications in Medicine (DICOM) standards. The filters are customizable by the user and organized in Metron-CP!MD'5 searchable database for later review. Users then have the ability to put together mnulti-page formatted reports that can be used in connection with other medical professionals, or provided as reference to patients. (See 21 CER 892.2050)

Source page: https://510kreport.com/device/K103554
Methodology: https://510kreport.com/methodology