510(k) · Cleared
Recalled · Class II · 2013550 TXT Treatment Table
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · JAI Couch, Radiation Therapy, Powered
Cleared on Mar 18, 2005 as substantially equivalent to K910971 (Siemens Medical Laboratories, Inc., 1991) after a 28-day review. Its family tree reaches back 1 generation to 1991. It has been recalled 3 times.
- Decided
- Mar 18, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- JAI
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910971 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK910971 Z XT Radiation Therapy Treatment TableSiemens Medical Laboratories, Inc. · 1991
- This deviceK050422 550 TXT Treatment TableSiemens Medical Solutions USA, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910971 | Z XT Radiation Therapy Treatment Table | Siemens Medical Laboratories, Inc. | 1991 | — |
| 0 (this device) | K050422 | 550 TXT Treatment Table | Siemens Medical Solutions USA, Inc. | 2005 | — |
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 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? (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 |
|---|---|---|---|
| * | K910971 | Z XT Radiation Therapy Treatment TableSummary page 1…ion Therapy, Powered Classification: 892.5770 Product Code: JAI Substantial Equivalence Claimed To: ZXT Treatment Table K910971 cleared on May 3, 1991 Description:… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 5, 2013 | Class II | Z-0787-2014 | Device Design | Update to correct the possibility for patients or operators to have their fingers trapped or pinched between the table top and the bottom frame of the 550 TxT Treatment Table. Combined with this update instruction is a second complaint… |
| Mar 31, 2010 | Not classified | Z-0166-2011 | Other | An increase in voltage may cause a short circuit of a power transistor that may cause a smoldering and smoking effect of the electrical wiring and also an unexpected lowering of the Table. Both issues present the potential for injury to a… |
| Mar 31, 2010 | Not classified | Z-2023-2011 | Component design/selection | Potential for causing overheating of the power supply during treatment, and potential for unexpected table descent. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K910971.
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 | — |
What is it indicated for?
The 550 TxT Treatment Table is to be used as an integral part of the Siemens linear accelerator systems to positiion the patient accurately according to the treatment plan for various radiation therapy treatment techniques. The table can be controlled either within the treatment room via the table interface or remotely from the linear accelerator control console.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050422: 550 TXT Treatment Table.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050422
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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