(28 days)
Not Found
No
The summary describes a mechanical treatment table with motorized movements and positioning capabilities, but there is no mention of AI or ML technology being used for control, positioning, or any other function.
No
The device is a treatment table, which is a patient support assembly used to position patients accurately for radiation therapy, but it does not directly administer or provide therapy itself. It is an accessory to the therapeutic linear accelerator system.
No
Explanation: The device is a treatment table used to position patients for radiation therapy. Its intended use is for treatment delivery, not for diagnosing medical conditions.
No
The device description clearly states it is a "powered radiation therapy patient support assembly" and describes physical components and movements (six degrees of freedom, motorized movements), indicating it is a hardware device.
Based on the provided information, the 550 TxT Treatment Table is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "position the patient accurately according to the treatment plan for the delivery of various radiation therapy treatment procedures." This is a function performed on the patient, not on a sample taken from the patient.
- Device Description: The description details a "powered radiation therapy patient support assembly" that provides motion and positioning capabilities. This aligns with a device used in a clinical setting for patient treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Therefore, the 550 TxT Treatment Table is a medical device used in radiation therapy for patient positioning, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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 procedures either manually with the free float function or smoothly by using the motorized movements or remotely from the linear accelerator control console.
Product codes
JAI
Device Description
The 550 TxT Treatment Table is a powered radiation therapy patient support assembly that is to be used in conjunction with Siemens linear accelerator systems. The 550 TxT Treatment Table design improves the quality of treatment delivery by providing greater positioning accuracy and higher load capacity as compared to the ZXT Treatment Table. The patient can be positioned on the treatment table either manually with the free float function or smoothly by using the motorized movements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5770 Powered radiation therapy patient support assembly.
(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.
0
SIEMENS
Tab 1 510(k) Summary
| Submitter: | Siemens Medical Solutions USA, Inc.
Oncology Care Systems Group
4040 Nelson Avenue
Concord, CA 94520 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Ken Nehmer
Senior Manager of Regulatory Affairs |
| Phone:
Fax:
Email: | (925)602-8011
(925)602-8008
ken.nehmer@siemens.com |
| 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
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.
1
Image /page/1/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is in a simple, sans-serif font and is left-aligned.
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.
2
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
3
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) | ✓ |
| Over-the-Counter Use |