Cleared Traditional

K081281 - OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)

K081281 is an FDA 510(k) clearance for OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY), manufactured by Nucletron Corporation. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K081281 · Nucletron Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
14d
Days
Class 2
Risk

K081281 is an FDA 510(k) clearance for the OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY). Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Nucletron Corporation (Columbia, US). The FDA issued a Cleared decision on May 20, 2008 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nucletron Corporation devices

FDA 510(k) Submission Details - K081281

510(k) Number K081281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2008
Decision Date May 20, 2008
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Intertek Testing Services
DANIEL W LEHTONEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MUJ System, Planning, Radiation Therapy Treatment

All 160
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K081281.
PINNACLE3 SMARTARC
K090808 · Philips Medical Systems, Inc. · Apr 2009
ONCENTRA RT VIEWER 1.0
K082642 · Nucletron Corporation · Nov 2008
MODEIFICATION TO IPLAN RT DOSE
K080888 · Brainlab AG · Jun 2008
ONCENTRA GYN
K080929 · Nucletron Corporation · Apr 2008
ECLIPSE TREATMENT PLANNING SYSTEM
K073020 · Varian Medical Systems, Inc. · Dec 2007
MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM
K071760 · Varian Medical Systems, Inc. · Nov 2007