Patxfer RT
FDA 510(k) K040931 · Brainlab AG
510(k) numberK040931
Submission
- Device name
- Patxfer RT
- Applicant
- Brainlab AG
Heimstetten, DE - Received
- April 9, 2004
- Decision date
- July 22, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Patxfer RT cleared by the FDA?
Patxfer RT (K040931) received a 510(k) decision of Substantially Equivalent on July 22, 2004, 104 days after the submission was received.
What is the product code of K040931?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.