# K060035: Mdxnet

- Pathway: 510(k) (Abbreviated)
- Applicant: Cybermdx, Inc.
- Decided: Mar 9, 2006 after 63 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: 4 generations back to K945188 (1995). 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)
- K012086: Aquariusnet Server, Terarecon,Inc. (2001) Summary page 2.
- K994329: Iivs Integrated Image Viewing Station, Terarecon,Inc. (2000) Summary page 2.
- K972903: Imatron Ultra Access Workstation with Cardiac Software Extensions, Imatron, Inc. (1997) Summary page 2.
- K013088: Echotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive, Echotech Quanticon, Echotech Easystress, Echotech 3D Imaging Systems, Inc. (2002) Summary page 2.

## Indications for use
MDxNet is intended for use under physician's orders and/or oversight and management. MDxNet is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images in the adult and pediatric patient utilizing existing ultrasound systems. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 2D and 3D image processing. MDxNet is indicated to acquire, digitize, archive and retrieve single or sequences of 2D ultrasound images. MDxNet is intended as a general purpose digital image processing and archiving tool for use in abdominal, pelvic, fetal, cardiac, peripheral vascular and neurovascular imaging. MDxNet add-on indications are for the assessment of pulmonary function to acquire, analyze, store and retrieve this assessment in male/female adult and pediatric patients utilizing FDA approved Spirometry. MDxNet additional add-on will provide 12-lead resting electrocardiogram (ECG) which permits the detection of abnormalities in the transmission of the cardiac impulse through the heart muscle and serves as an important aid in the diagnosis of heart ailments through utilizing 12-lead ECG. MDxNet intended use is for medical clinics, including though not limited to infirmary, hospital, military, remote and urban clinics.

Source page: https://510kreport.com/device/K060035
Methodology: https://510kreport.com/methodology