# K973010: Realtime 3D Diagnostic Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 10, 1997 after 89 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
No predicates in its family tree.
386 later devices descend from it; 5 cite it directly.
1 of 387 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Vitrea™ 3D Medical Visualization System: named in the summary without a submission number
- (no number) MagicView Diagnostic Workstation: named in the summary without a submission number

## Most influential descendants
- K030982: Syngo Colonography Software Package (2003), 227 descendants of its own
- K033102: Medic Colon Model, Release 1 (2003), 210 descendants of its own
- K042674: Colon Car 1.2 (2004), 209 descendants of its own
- K023003: Imagechecker-CT Workstation (2002), 177 descendants of its own
- K032748: VITREA2, Version 3.4 Medical Image Processing Software (2003), 170 descendants of its own

## Indications for use
From user specified sets of CT or MR images, Realtime 3D can be uscd for 3D presentation of the complete anatomic structure (i.c. head, chest, abdomcn) covered by the original CT or MR images for diagnosis and use in treatment planning; diagnosing as well as treatment planning [rom real time Multi-Planar-Reconstruction (MPR):the Realtime 3D too! can help the user to pusilion and visualize the 3-dimensional location of the MPR within the 3D volume by using interactive clip planes in real time; CTA and MRA displaying cnhanced vessels; measurement of anatomical saucturcs in the 3D volume. Important for quantitative measurcment of geometry and length of anatomy indices: displaying the position of anatomical structures in relaionship to cach other; navigating interactively through anatomical structures (e.g., vesscls, colon, spine, lung, etc.) or inside the 3D volume; depth perception using the Sterco display option to visualize i.e. overlaying and underlying vessels: far viewing the inner surface of organs (vessels, colon, etc.);

Source page: https://510kreport.com/device/K973010
Methodology: https://510kreport.com/methodology