Cleared Traditional

K983660 - EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)

K983660 is an FDA 510(k) clearance for EXACTRAC (BRAINLAB PATIENT POSITIONING ..., manufactured by Brainlab, Inc.. The device is a Class 2 Radiology device with product code LHN cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K983660 · Brainlab, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
268d
Days
Class 2
Risk

K983660 is an FDA 510(k) clearance for the EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM). Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Brainlab, Inc. (Palo Alto, US). The FDA issued a Cleared decision on July 14, 1999 after a review of 268 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, Inc. devices

FDA 510(k) Submission Details - K983660

510(k) Number K983660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1998
Decision Date July 14, 1999
Days to Decision 268 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 107d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHN Device Classification - Class 2, Special Controls

Product Code LHN System, Radiation Therapy, Charged-particle, Medical
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 - LHN System, Radiation Therapy, Charged-particle, Medical

All 43
Devices cleared under the same product code (LHN) and FDA review panel - the closest regulatory comparables to K983660.
NORTHEAST PROTON THERAPY CENTER
K983332 · Massachusetts General Hospital · Jul 2001
PROTON THERAPY SYSTEM
K983024 · Ion Beam Applications S.A. · Jul 2001
TREATVISION
K002194 · Varian Medical Systems, Inc. · Aug 2000
RPM RESPIRATORY GATING SYSTEM
K983629 · Varian Medical Systems, Inc. · Jun 1999
IMFAST
K982952 · Siemens Medical Solutions USA, Inc. · Mar 1999
MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE
K983342 · Philips Medical Systems (Cleveland), Inc. · Dec 1998