550 TXT Treatment Table
FDA 510(k) K050422 · Siemens Medical Solutions USA, Inc.
510(k) numberK050422
Submission
- Device name
- 550 TXT Treatment Table
- Applicant
- Siemens Medical Solutions USA, Inc.
Concord, CA, US - Received
- February 18, 2005
- Decision date
- March 18, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was 550 TXT Treatment Table cleared by the FDA?
550 TXT Treatment Table (K050422) received a 510(k) decision of Substantially Equivalent on March 18, 2005, 28 days after the submission was received.
What is the product code of K050422?
The FDA product code is JAI – Couch, Radiation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.5770.