510(k) · Cleared
ClearedRTR-2000/RTR-4000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terarecon,Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 13, 1998 as substantially equivalent to K950972 (Toshiba America Medical Systems, In.C, 1996) after an 88-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Feb 13, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950972 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK950972 Real-Time Reconstruction System Model TSXF-001AToshiba America Medical Systems, In.C · 1996
- This deviceK974307 RTR-2000/RTR-4000Terarecon,Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950972 | Real-Time Reconstruction System Model TSXF-001A | Toshiba America Medical Systems, In.C | 1996 | — |
| 0 (this device) | K974307 | RTR-2000/RTR-4000 | Terarecon,Inc. | 1998 | — |
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 |
|---|---|---|---|
| * | K950972 | Real-Time Reconstruction System Model TSXF-001ASummary page 1…90LLZ Establishment Registration Number: Application in Process Predicate Device: Toshiba TSFX-001A, Real-Time Reconstruction System Option for Xpress/SX CT System, K950972 Device Description: The TERARECON, INC. RTR-2000 real-time image reconstruction system acquires medical image data from such med… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K950972.
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?
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…
Read the full statement (147 words)
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.
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/K974307 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974307: RTR-2000/RTR-4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974307
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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