510(k) · Cleared
ClearedZ XT Radiation Therapy Treatment Table
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Laboratories, Inc. · JAI Couch, Radiation Therapy, Powered
Cleared on May 3, 1991 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- May 3, 1991
- Review
- 57 days
- Class
- Class II
- Product code
- JAI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK910971 Z XT Radiation Therapy Treatment TableSiemens Medical Laboratories, Inc. · 1991
- Descendant · cites it directly · 0 of its ownK050422 550 TXT Treatment TableSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · cites it directly · 0 of its ownK993522 Aktina Medical Physics Corporation Tennis Racquet InsertAktina Medical Physics Corp. · 2000
- Descendant · cites it directly · 0 of its ownK982446 Dynamic Shielding Radiation TableAmerican Biophysics, Inc. · 1998
Most influential descendants
Showing 3 of 3 · See all- K050422550 TXT Treatment TableSiemens Medical Solutions USA, Inc. · 2005 · cites it directly0descendants
- K993522Aktina Medical Physics Corporation Tennis Racquet InsertAktina Medical Physics Corp. · 2000 · cites it directly0descendants
- K982446Dynamic Shielding Radiation TableAmerican Biophysics, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910971 | Z XT Radiation Therapy Treatment Table | Siemens Medical Laboratories, Inc. | 1991 | — |
| +1 | K050422 | 550 TXT Treatment Table | Siemens Medical Solutions USA, Inc. | 2005 | 3 |
| +1 | K993522 | Aktina Medical Physics Corporation Tennis Racquet Insert | Aktina Medical Physics Corp. | 2000 | — |
| +1 | K982446 | Dynamic Shielding Radiation Table | American Biophysics, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 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 JAI? 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 JAI device
- #1 K231612 Eve Patient Positioner Systemscore 7.9 · 3 generations · no Class I recall
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? (3)
3 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, K050422 (Siemens Medical Solutions USA, Inc., 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JAI devicesJAI Couch, Radiation Therapy, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JAI
61in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAI
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAI
1in 2024
MAUDE reports naming product code JAI, 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 | 2 | — | 1 | 4 |
| 2008 | 0 | — | 2 | 2 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 2 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 61 | 0 | 2 |
| 2013 | 1 | — | 2 | 5 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 1 | — | 1 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 2 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K910971 · printed Nov 5, 2026
Cite this page
510(k) Report. “K910971: Z XT Radiation Therapy Treatment Table.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K910971
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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