Cleared Traditional

K994413 - BRAINSCAN

K994413 is an FDA 510(k) clearance for BRAINSCAN, manufactured by Brainlab AG. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K994413 · Brainlab AG · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
197d
Days
Class 2
Risk

K994413 is an FDA 510(k) clearance for the BRAINSCAN. 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 July 13, 2000 after a review of 197 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Brainlab AG devices

FDA 510(k) Submission Details - K994413

510(k) Number K994413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1999
Decision Date July 13, 2000
Days to Decision 197 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
90d slower than avg
Panel avg: 107d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - MUJ System, Planning, Radiation Therapy Treatment

All 222
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K994413.
FOCUS
K002147 · Computerized Medical Systems, Inc. · Oct 2000
PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM
K993675 · Nomos Corp. · Sep 2000
PROTON VISION 7.0
K002312 · Varian Medical Systems, Inc. · Aug 2000
XPLAN 2.1
K001700 · Radionics, Inc. · Jun 2000
OPTIRAD
K993895 · Permedics, Inc. · Jun 2000
PROTON VISION
K000922 · Varian Assoc., Inc. · May 2000