# K950972: Real-Time Reconstruction System Model TSXF-001A

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Apr 15, 1996 after 410 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have 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) TSX-011A (Xpress CT System): named in the summary without a submission number

## Most influential descendants
- K974344: CT Scope (1998), 0 descendants of its own
- K974307: RTR-2000/RTR-4000 (1998), 0 descendants of its own

## Indications for use
Computed Tomography X-Ray Scanners generally support three modes of imaging: 1) Multiple contiguous slices: conventional CT where individual slices of axial data are acquired, with the table advancing a set distance until a volume of interest is covered. 2) Helical Scanning: a volume of interest is scanned continuously while the patient table is advanced longitudinally, until a desired volume of data is acquired. 3) Dynamic scanning: a single slice location is scanned repeatedly over a period of time. Using the Real-Time Reconstruction System (RTRS) Option, the scanner effectively operates in the dynamic scan mode with the added flexibility of table and/or gantry movement during scanning. Under the control of the operating physician the RTRS is intended to speed up interventional procedures typically performed on CT. By permitting the operator to view the scanned area in virtual real time the RTRS is intended to support existing CT system clinical uses by offering enhanced operator flexibility coupled with the potential of reduced scan time. Features included with the RTRS to help control patient radiation dose are: 1) Use of an attenuating filter which is moved automatically into the x-ray beam when the RTRS mode is selected. 2) Automatic interruption of scanning after a maximum period of one hundred seconds. 3) Display of the elapsed scan time on the in-room viewing monitor.

Source page: https://510kreport.com/device/K950972
Methodology: https://510kreport.com/methodology