Clearance Summary
ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY received FDA 510(k) clearance under submission number K121448, sponsored by Elekta Inc. D/B/A Nucletron Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2012-07-02.
- Submission: K121448
- Applicant / Sponsor: Elekta Inc. D/B/A Nucletron Corporation
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2012-07-02
Classification & Regulation
This clearance is catalogued under FDA product code MUJ and 21 CFR 892.5050, within the Radiology review panel as a Class II device.