510(k) · Cleared
ClearedDose Tracking System Model Xidf-DTS801
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Feb 13, 2013 as substantially equivalent to K982319 (Siemens Medical Solutions USA, Inc., 1998) after a 134-day review. Its family tree reaches back 2 generations to 1985. 9 later devices descend from it.
- Decided
- Feb 13, 2013
- Review
- 134 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K853753 (1985). 9 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK853753 Diamentor Patient X-Ray Exposure Indicator 07302Victoreen, Inc. · 1985
- 1 generation backK982319 CaregraphSiemens Medical Solutions USA, Inc. · 1998
- This deviceK123097 Dose Tracking System Model Xidf-DTS801Toshiba America Medical Systems, In.C · 2013
- Descendant · cites it directly · 8 of its ownK132106 Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C · 2013
- Descendant · 2 generations on · 7 of its ownK141541 Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation · 2014
- Descendant · 3 generations on · 6 of its ownK142736 XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation · 2015
- Descendant · 4 generations on · 5 of its ownK150967 XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation · 2015 · Recalled
- Descendant · 5 generations on · 4 of its ownK152785 XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation · 2015 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C · 2013 · cites it directly8descendants
- K141541Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation · 2014 · 2 generations on7descendants
- K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation · 2015 · 3 generations on6descendants
- K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation · 2015 · 4 generations on5descendants
- K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation · 2015 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K853753 | Diamentor Patient X-Ray Exposure Indicator 07302 | Victoreen, Inc. | 1985 | — |
| −1 | K982319 | Caregraph | Siemens Medical Solutions USA, Inc. | 1998 | — |
| 0 (this device) | K123097 | Dose Tracking System Model Xidf-DTS801 | Toshiba America Medical Systems, In.C | 2013 | — |
| +1 | K132106 | Infinix Angio Workstation W/DTS Software | Toshiba America Medical Systems, In.C | 2013 | — |
| +2 | K141541 | Xidf-AWS801, Angio Workstation, V5.31 | Toshibamedical Systems Corporation | 2014 | — |
| +3 | K142736 | XIDF-AWS801, Angio Workstation, v5.31 | Toshibamedical Systems Corporation | 2015 | — |
| +4 | K150967 | XIDF-AWS801, Angio Workstation, V6.10 | Toshibamedical Systems Corporation | 2015 | 1 |
| +5 | K152785 | XIDF-AWS801, Angio Workstation, V6.20 | Toshibamedical Systems Corporation | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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 JAA? 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 JAA device
- #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 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 |
|---|---|---|---|
| * | K982319 | CaregraphSummary page 1…ed fluoroscopic x-ray system. 9. PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard 10. PREDICATE DEVICE: Siemens CAREGRAPH, K982319 11. REASON FOR SUBMISSION: Modification of a cleared device - INFX-8000F; K081624… | 1998 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132106 | Infinix Angio Workstation W/DTS Software | 2013 | 8 |
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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 14.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K132106 (Toshiba America Medical Systems, In.C, 2013) has gone furthest, with 8 descendants of its own.
How does its category compare?
All JAA devicesJAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JAA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAA
89in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAA
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAA
33in 2025
MAUDE reports naming product code JAA, 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 | 1 | — | 35 | 9,517 |
| 2008 | 6 | 18 | 21 | 9,484 |
| 2009 | 0 | — | 18 | 12,040 |
| 2010 | 1 | — | 6 | 5,803 |
| 2011 | 4 | 48 | 7 | 14,000 |
| 2012 | 1 | — | 2 | 11,684 |
| 2013 | 6 | 129 | 3 | 13,706 |
| 2014 | 6 | 276 | 1 | 10,265 |
| 2015 | 3 | 197 | 1 | 2,922 |
| 2016 | 2 | — | 7 | 35 |
| 2017 | 1 | — | 3 | 56 |
| 2018 | 3 | 30 | 1 | 36 |
| 2019 | 6 | 49 | 2 | 49 |
| 2020 | 4 | 39 | 2 | 39 |
| 2021 | 6 | 104 | 2 | 35 |
| 2022 | 1 | — | 5 | 34 |
| 2023 | 2 | — | 9 | 41 |
| 2024 | 3 | 89 | 2 | 25 |
| 2025 | 2 | — | 4 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
DTS is intended to display an approximation of both skin dose distribution and skin dose rate in real time during fluoroscopic interventional procedures of cardiac angiography.
This software is intended for use on the Toshiba INFX-8000F CSi cardiac labs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123097 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123097: Dose Tracking System Model Xidf-DTS801.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123097
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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