Cleared Special

K203173 - ExacTrac Dynamic

K203173 is an FDA 510(k) clearance for ExacTrac Dynamic, manufactured by Brainlab AG. The device is a Class 2 Radiology device with product code IYE cleared through the Special 510(k) pathway after a 17-day FDA review.

K203173 · Brainlab AG · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
17d
Days
Class 2
Risk

K203173 is an FDA 510(k) clearance for the ExacTrac Dynamic. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on November 12, 2020 after a review of 17 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Brainlab AG devices

FDA 510(k) Submission Details - K203173

510(k) Number K203173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2020
Decision Date November 12, 2020
Days to Decision 17 days
Submission Type Special
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 faster than avg
Panel avg: 107d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, 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 - IYE Accelerator, Linear, Medical

All 331
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K203173.
ClearRT Helical kVCT for the Radixact Treatment Delivery System
K202412 · Accuray Incorporated · Dec 2020
MOSAIQ Oncology Information System
K203172 · Elekta Solutions AB · Dec 2020
BeamSite
K200940 · Doseoptics, LLC · Dec 2020
Cranial 4Pi Immobilization
K202050 · Brainlab AG · Aug 2020
The AIO Solution 3.0
K202068 · Orfit Industries NV · Aug 2020
TaiChiA
K193207 · Our United Corporation · Aug 2020