510(k) · Cleared
ClearedReal-Time Reconstruction System Model TSXF-001A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 15, 1996 after a 410-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Apr 15, 1996
- Review
- 410 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950972 | Real-Time Reconstruction System Model TSXF-001A | Toshiba America Medical Systems, In.C | 1996 | — |
| +1 | K974344 | CT Scope | Elscint, Inc. | 1998 | — |
| +1 | K974307 | RTR-2000/RTR-4000 | Terarecon,Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JAK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | TSX-011A (Xpress CT System) Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K974344 (Elscint, Inc., 1998) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
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…
Read the full statement (219 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K950972 · printed Nov 4, 2026
Cite this page
510(k) Report. “K950972: Real-Time Reconstruction System Model TSXF-001A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950972
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026