Ocentra Masterplan 3.1 (Ocentra Brachy)
FDA 510(k) K081281 · Nucletron Corporation
510(k) numberK081281
Submission
- Device name
- Ocentra Masterplan 3.1 (Ocentra Brachy)
- Applicant
- Nucletron Corporation
Columbia, MD, US - Received
- May 6, 2008
- Decision date
- May 20, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K091598 | Lumencath Applicator Set, Models 189. 795, 189.796, 189.797, 189.798, Lumencath CathetersJAQ · Special | 06/29/2009SE |
| K090706 | Oncentra Simulation 2.3KPQ · Traditional | 06/15/2009SE |
| K091154 | Utrecht Interstitial Fletcher Ct/Mr Applicator Set, Model 110.270, Interstitial Ring…JAQ · Special | 05/18/2009SE |
| K082642 | Oncentra RT Viewer 1.0MUJ · Traditional | 11/07/2008SE |
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Questions and answers
When was Ocentra Masterplan 3.1 (Ocentra Brachy) cleared by the FDA?
Ocentra Masterplan 3.1 (Ocentra Brachy) (K081281) received a 510(k) decision of Substantially Equivalent on May 20, 2008, 14 days after the submission was received.
What is the product code of K081281?
The FDA product code is MUJ – System, Planning, Radiation Therapy Treatment, a Class II (moderate risk) device regulated under 21 CFR 892.5050.