Cleared Traditional

K120520 - EXACTRAC ROBOTICS NOVALIS ROBOTICS

K120520 is an FDA 510(k) clearance for EXACTRAC ROBOTICS NOVALIS ROBOTICS, manufactured by Brainlab AG. The device is a Class 2 Radiology device with product code JAI cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K120520 · Brainlab AG · Radiology device
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Jun 2012
Decision
129d
Days
Class 2
Risk

K120520 is an FDA 510(k) clearance for the EXACTRAC ROBOTICS NOVALIS ROBOTICS. Classified as Couch, Radiation Therapy, Powered (product code JAI), Class II - Special Controls.

Submitted by Brainlab AG (Feldkirchen, DE). The FDA issued a Cleared decision on June 29, 2012 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5770 - 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 - K120520

510(k) Number K120520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2012
Decision Date June 29, 2012
Days to Decision 129 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
22d slower than avg
Panel avg: 107d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAI Device Classification - Class 2, Special Controls

Product Code JAI Couch, Radiation Therapy, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5770
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 - JAI Couch, Radiation Therapy, Powered

All 19
Devices cleared under the same product code (JAI) and FDA review panel - the closest regulatory comparables to K120520.
PROTURA COUCH SOFTWARE
K132084 · Med-Tec, Inc. D/B/A Civco Medical Solutions · Sep 2013
PATIENT POSITIONING SYSTEM
K122413 · Forte Automation Systems, Inc. · Sep 2012
PROTURA COUCH SOFTWARE
K122201 · Med-Tec, Inc. D/B/A Civco Medical Solutions · Aug 2012
QFIX RADIOTHERAPY CHAIR
K120916 · Wfr/Aquaplast Corp. · Jun 2012
550 TXT TREATMENT TABLE
K050422 · Siemens Medical Solutions USA, Inc. · Mar 2005
ROBOCOUCH PATIENT SUPPORT SYSTEM
K042146 · Accuray Incorporated · Sep 2004