ONCENTRA BRACHY— 510(k) K132816
Substantially EquivalentNucletron B.V.
FDA 510(k) clearance K132816 for ONCENTRA BRACHY, Substantially Equivalent on 2014-06-13. Applicant: Nucletron B.V.. Device class: 2.
Clearance details
- Applicant
- Nucletron B.V.
- 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
- Rice Lake, WI, US
Recent devices under product code MUJ
view allMore clearances from Nucletron B.V.
view allRecalls naming K132816
K-number listed on FDA's recall record- Z-0719-2023 — Oncentra Brachy radiation therapy planning system software.
- Z-0182-2022 — Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
- Z-0050-2018 — Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132816.
Data sourced from openFDA. This site is unofficial and independent of the FDA.