510(k) K081281
K081281 is an FDA 510(k) premarket notification submitted by Nucletron Corporation for the device "OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)". The FDA issued a decision of Substantially Equivalent on May 20, 2008. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Nucletron Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2008
- Date Received
- May 6, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Planning, Radiation Therapy Treatment
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type