OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)— 510(k) K081281
Substantially EquivalentNucletron Corporation
FDA 510(k) clearance K081281 for OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY), Substantially Equivalent on 2008-05-20. Applicant: Nucletron Corporation. Device class: 2.
Clearance details
- Applicant
- 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
- Columbia, MD, US
Recent devices under product code MUJ
view allMore clearances from Nucletron Corporation
view all- K103515 — EQUAL DOSE
- K090706 — ONCENTRA SIMULATION 2.3
- K091154 — UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330,
- K082642 — ONCENTRA RT VIEWER 1.0
- K080934 — VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET
Recalls naming K081281
K-number listed on FDA's recall record- 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.
- Z-0118-2013 — Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension 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 K081281.
Data sourced from openFDA. This site is unofficial and independent of the FDA.