# K960911: Netra Workstation System & Netra MD Software

- Pathway: 510(k) (Traditional)
- Applicant: Scimage, Inc.
- Decided: May 29, 1996 after 84 days
- Product code: LMD (System, Digital Image Communications, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2020
- 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 K945428 (1995). 1 ancestor in all.
207 later devices descend from it; 4 cite it directly.
0 of 209 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945428: Scribe (TM) Diagnostic Imaging Workstation, Multi-Dimensional Imaging, Inc. (1995) Summary page 1.

## Most influential descendants
- K990426: Calcium Scoring (1999), 166 descendants of its own
- K043111: Plaqueview Software, Model CSPV-0001A (2004), 112 descendants of its own
- K061624: Vitrea, Version 3.9 (2006), 111 descendants of its own
- K071331: Vitrea Version 4.0 (2007), 82 descendants of its own
- K072737: CSCS-001A Calcium Scoring Package (2007), 45 descendants of its own

## Indications for use
The Netra™ Workstation System and NetraMD™ Software is intended for viewing and manipulation of high quality MRJ, CT, Ultrasound and X-ray electronic images as an aid in diagnosis for the trained medical practitioner. The NetraMD™ Software system in conjunction with NETRA™ Imaging Workstation system is used for: 1.) receiving and storing of image data from a ACR/NEMA DICOM 3.0 compatible medical imaging scanning device, ACC/ACR/NEMA (DICOM 3.0) Digital Interchange Standard for Cardiology (DISC95-96) storage media, direct digital transfer from a medical imaging scanning device and video frame capture from a medical imaging scanning device. 2.) displaying and reviewing received images in individual image windows with window/level and panning/zooming controls, reformatting of 3D and 4D volumes in orthogonal and oblique planes, volumetric presentation of 3D and 4D volumes using 3D reconstruction and rendering, measurement of distances, areas and volumes, and manual segmentation of structures of interest for 3D presentation. 3.) sending image data to ACR/NEMA DICOM 3.0 compatible equipment, ACC/ACR/NEMA (DICOM 3.0) Digital Interchange Standard for Cardiology storage media, printer, scanning device monitor, independent monitor or other device for purpose of communication, archiving, review and display of medical diagnostic images.

Source page: https://510kreport.com/device/K960911
Methodology: https://510kreport.com/methodology