550 TXT TREATMENT TABLE

K050422 · Siemens Medical Solutions USA, Inc. · JAI · Mar 18, 2005 · Radiology

Device Facts

• Record ID: K050422
• Device Name: 550 TXT TREATMENT TABLE
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAI · Radiology
• Decision Date: Mar 18, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 550 TxT Treatment Table is to be used as an integral part of the Siemens linear accelerator systems to position the patient accurately according to the treatment plan for various radiation therapy treatment via the table interface or remotely from the linear accelerator control console.

Device Story

The 550 TxT Treatment Table is a powered patient support assembly for radiation therapy. It integrates with Siemens linear accelerator systems to provide precise patient positioning. The table supports isocentric rotation, column rotation, and longitudinal, lateral, and vertical motions. Operation occurs via a table interface or remotely from the linear accelerator control console. The device features a free-float function for manual positioning and motorized movements for smooth adjustment. It offers improved positioning accuracy and higher load capacity compared to the predicate ZXT Treatment Table. The device is intended for clinical use by trained personnel to facilitate accurate radiation delivery, potentially improving treatment quality.

Clinical Evidence

Bench testing only.

Technological Characteristics

Powered radiation therapy patient support assembly. Features motorized and manual (free-float) positioning capabilities. Supports isocentric, longitudinal, lateral, and vertical motion axes. Designed for integration with Siemens linear accelerator systems. No specific materials or software algorithm details provided.

Indications for Use

Indicated for patients requiring radiation therapy, to be used as an integral part of Siemens linear accelerator systems for accurate patient positioning according to a treatment plan.

Regulatory Classification

Identification

A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.

Predicate Devices

• ZXT Treatment Table (K910971)

Submission Summary (Full Text)

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**SIEMENS**

K050422

## Tab 1 510(k) Summary

| Submitter: | Siemens Medical Solutions USA, Inc.<br>Oncology Care Systems Group<br>4040 Nelson Avenue<br>Concord, CA 94520 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Ken Nehmer<br>Senior Manager of Regulatory Affairs |
| Phone:<br>Fax:<br>Email: | [phone]<br>[phone]<br>[e-mail] |
| Proprietary Name: | 550 TxT Treatment Table |
| Common Name: | Couch, Radiation Therapy, Powered |
| Classification: | 892.5770 |
| Product Code: | JAI |
| Substantial Equivalence Claimed To: | ZXT Treatment Table<br>K910971 cleared on May 3, 1991 |

## Description:

The 550 TxT Treatment Table is a powered radiation therapy patient support assembly that is and The 550 TXT Treatment Table is a powered hadded the many fable (K910971). Refer to Table in the Sand equivalent in functionally as the providely the 550 TxT Treatments and specifications.

The 550 TxT Treatment Table is to be used in conjunction with Siemens linear accelerator systems. The I he 550 TXT Treatment Table is to be used information man Boss including isocentric rotation, column rotation, longitudinal, lateral, and vertical motions.

The 550 TxT Treatment Table design improves the quality of treatment delivery by providing greatent The SSU TXT Treatment Table dolgh Improved to the ZXT Treatment Table. The news positioning accuracy and higher load capacity as bompared to the treatment table either manually with the free float function or smoothly by using the motorized movements.

## Intended Use:

The 550 TxT Treatment Table is to be used as an integral part of the Siemens linear accelerator systems to The 350 TXT Treathern Trable is to be dood to an integral or various radiation therapy treatment position the patient accurately according to the treatment room via the table interface or remotely from the linear accelerator control console.

## Siemens Medical Solutions USA, Inc.

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MAR 1 8 2005

Mr. Ken Nehmer Senior Manager of Regulatory Affairs Siemens Medical Solutions USA, Inc. Oncology Care Systems Group 4040 Nelson Avenue CONCORD CA 94520

Re: K050422

Trade/Device Name: 550 TxT Treatment Table Regulation Number: 21 CFR §892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II Product Code: JAI Dated: February 16, 2005 Received: February 18, 2005

Dear Ms. Dunbar:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in above and nate to legally marketed predicate devices marketed in interstate commerce prior to the cholors and regard ment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the do not require approvisions of the Act. The general controls provisions provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I tease of advisou that your device complies with other requirements of the Act or any I Dri has made a acternations administered by other Federal agencies. You must comply with all the I caral batered ate 200 Act 3 requirements, moraling practice requirements as set forth in the quality systems (QS) (2) CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin hanceinig your antial equivalence of your device to a legally premarket notification. The PDA Inding of Sacsantal organ mirice and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our laboring regarded on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification the Also, please note the regulation entition, "Thisoration on your responsibilities under the Act from the 807.97). You may outain other general meeticance at its toll-free number (800) Division of Sillan Manufacturers, Internet address http://www.fda.gov/cdrb/dsmamain.html

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K050422

510(k) Number (if known):

Device Name: 550 TxT Treatment Table

Indications for Use:

The 550 TxT Treatment Table is to be used as an integral part of the Siements linear accelerator systems to The 550 TXT Treatment Table is to be used to an investiality of various radiation therapy treatment position the patient accurately according to the treatment plan for value interface or remotely from the linear accelerator control console.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K050422 |
|---------------------------------------|--------------|
| Prescription Use (Per 21 CFR 801.109) | <div>✓</div> |
| Over-the-Counter Use | |