510(k) K050843
K050843 is an FDA 510(k) premarket notification submitted by Xoft, Inc. for the device "AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent - With Limitations on Dec 22, 2005. The device falls under product code JAD (System, Therapeutic, X-Ray), a Class II device regulated under 21 CFR 892.5900. Xoft, Inc. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESU (Substantially Equivalent - With Limitations)
- Decision Date
- Dec 22, 2005
- Date Received
- Apr 1, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Therapeutic, X-Ray
- Device Class
- Class II
- Regulation Number
- 892.5900
- Review Panel
- RA
- Submission Type
- 510(k)