510(k) · Cleared
Recalled · 2003TDA-4000/A4
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 May 13, 1994 after a 39-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 60 later devices descend from it. It has been recalled once.
- Decided
- May 13, 1994
- Review
- 39 days
- Class
- Class II
- Product code
- JAA
- Recalls
- 1
- Predicates
- 0
60 later devices descend from it, 1 citing it directly.
- This deviceK941611 TDA-4000/A4Toshiba America Medical Systems, In.C · 1994
- Descendant · cites it directly · 59 of its ownK013608 Digital Radiography System, Model DFP-8000DToshiba America Medical Systems, In.C · 2001 · Recalled
- Descendant · 2 generations on · 57 of its ownK052884 Model DFP-8000D/FPD Digital Radiography System with Flat Panel…Toshiba America Medical Systems, In.C · 2005 · Recalled
- Descendant · 3 generations on · 23 of its ownK081582 Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · Recalled
- Descendant · 4 generations on · 21 of its ownK101868 Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C · 2010
- Descendant · 5 generations on · 20 of its ownK120073 Infx-8000V withToshibamedical Systems Corporation · 2012 · Recalled
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K013608Digital Radiography System, Model DFP-8000DToshiba America Medical Systems, In.C · 2001 · cites it directly59descendants
- K052884Model DFP-8000D/FPD Digital Radiography System with Flat Panel DetectorToshiba America Medical Systems, In.C · 2005 · 2 generations on57descendants
- K081582Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · 3 generations on23descendants
- K101868Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C · 2010 · 4 generations on21descendants
- K120073Infx-8000V withToshibamedical Systems Corporation · 2012 · 5 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941611 | TDA-4000/A4 | Toshiba America Medical Systems, In.C | 1994 | — |
| +1 | K013608 | Digital Radiography System, Model DFP-8000D | Toshiba America Medical Systems, In.C | 2001 | 2 |
| +2 | K052884 | Model DFP-8000D/FPD Digital Radiography System with Flat Panel Detector | Toshiba America Medical Systems, In.C | 2005 | 2 |
| +3 | K081582 | Infx-8000V, Infinix-Cfi and Infinix Vfi | Toshiba America Medical Systems, In.C | 2008 | 1 |
| +4 | K101868 | Infinix-I Interventional Angiography System Model Infx-8000V | Toshiba America Medical Systems, In.C | 2010 | — |
| +5 | K120073 | Infx-8000V with | Toshibamedical Systems Corporation | 2012 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 10 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (60)
See all 601 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013608 | Digital Radiography System, Model DFP-8000D | 2001 | 59 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 27, 2003 | Not classified | Z-0100-04 | Other | Images display with wrong patient demographics. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K013608 (Toshiba America Medical Systems, In.C, 2001) has gone furthest, with 59 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.
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 | — |
https://510kreport.com/device/K941611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941611: TDA-4000/A4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941611
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026