# K050422: 550 TXT Treatment Table

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 18, 2005 after 28 days
- Product code: JAI (Couch, Radiation Therapy, Powered)
- Device class: 2
- Regulation: 21 CFR 892.5770
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910971 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910971: Z XT Radiation Therapy Treatment Table, Siemens Medical Laboratories, Inc. (1991) Summary page 1.

## Recalls of this device
- Dec 5, 2013 · Class II · Z-0787-2014: 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 updat
- Mar 31, 2010 · Not classified · Z-0166-2011: 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
- Mar 31, 2010 · Not classified · Z-2023-2011: Potential for causing overheating of the power supply during treatment, and potential for unexpected table descent.

## Indications for use
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.

Source page: https://510kreport.com/device/K050422
Methodology: https://510kreport.com/methodology