ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY— 510(k) K121448
Substantially EquivalentElekta Inc. D/B/A Nucletron Corporation
FDA 510(k) clearance K121448 for ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY, Substantially Equivalent on 2012-07-02. Applicant: Elekta Inc. D/B/A Nucletron Corporation. Device class: 2.
Clearance details
- Applicant
- Elekta Inc. D/B/A Nucletron Corporation
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baltimore, MD, US
Recent devices under product code MUJ
view allRecalls naming K121448
K-number listed on FDA's recall record- Z-0987-2017 — Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer.
- Z-0604-2016 — Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
- Z-1712-2015 — Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121448.
Data sourced from openFDA. This site is unofficial and independent of the FDA.