# K974307: RTR-2000/RTR-4000

- Pathway: 510(k) (Traditional)
- Applicant: Terarecon,Inc.
- Decided: Feb 13, 1998 after 88 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K950972 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950972: Real-Time Reconstruction System Model TSXF-001A, Toshiba America Medical Systems, In.C (1996) Summary page 1.

## Indications for use
The TeraRecon RTR-2000 Image Reconstruction System should be used when it is desirable to view scanned medical images immediately, rather than wait long periods of time for reconstruction. Indications would incilude monitoring of radiological examinations for patient movement. It is possible that patient movement during the middle of an examination, which may require re-scanning, would not be detected until after the completion of the exam when all of the images are reconstructed and thus visualized. High speed image reconstruction allows for real-time visualization of the images. Such real-time visualization of images gives the immediate visual feedback necessary to monitor the progress of examinations in efforts to maximize scanning accuracy and minimize radiation dose to the patient. - In shonrt, real-time visualization of images is indicated in cases where the user prefers immediate visual feedback as opposed to having to wait long periods of time for image reconstruction.

Source page: https://510kreport.com/device/K974307
Methodology: https://510kreport.com/methodology