Cleared Traditional

K002509 - NOVALIS (SHAPED BEAM SURGERY SYSTEM)

K002509 is the FDA 510(k) clearance for NOVALIS (SHAPED BEAM SURGERY SYSTEM) by Brainlab AG. It is a Class 2 Radiology device (product code MUJ) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K002509 · Brainlab AG · Radiology device
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Nov 2000
Decision
80d
Days
Class 2
Risk

K002509 is an FDA 510(k) clearance for the NOVALIS (SHAPED BEAM SURGERY SYSTEM). Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Brainlab AG (Heimstetten, DE). The FDA issued a Cleared decision on November 3, 2000 after a review of 80 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 Brainlab AG devices

Submission Details

510(k) Number K002509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2000
Decision Date November 03, 2000
Days to Decision 80 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 107d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - MUJ System, Planning, Radiation Therapy Treatment

All 136
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K002509.
VARISEED 7.0
K012017 · Varian Medical Systems · Jul 2001
PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1
K010784 · Nucletron Corp. · Apr 2001
P3IMRT TM
K002237 · Adac Laboratories · Feb 2001
PROTON VISION 7.0
K002312 · Varian Medical Systems, Inc. · Aug 2000
BRAINSCAN
K994413 · Brainlab AG · Jul 2000
XPLAN 2.1
K001700 · Radionics, Inc. · Jun 2000