Cleared Special

K170058 - TheraView TBI

K170058 is an FDA 510(k) clearance for TheraView TBI, manufactured by Cablon Medical B.V.. The device is a Class 2 Radiology device with product code IYE cleared through the Special 510(k) pathway after a 56-day FDA review.

K170058 · Cablon Medical B.V. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
56d
Days
Class 2
Risk

K170058 is an FDA 510(k) clearance for the TheraView TBI. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Cablon Medical B.V. (Leusden, NL). The FDA issued a Cleared decision on March 3, 2017 after a review of 56 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 Cablon Medical B.V. devices

FDA 510(k) Submission Details - K170058

510(k) Number K170058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2017
Decision Date March 03, 2017
Days to Decision 56 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 107d · This submission: 56d
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 367
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K170058.
TrueBeam, TrueBeam STx, Edge
K171733 · Varian Medical Systems, Inc. · Jul 2017
Halcyon
K170817 · Varian Medical Systems, Inc. · Jun 2017
Accuray Precision Treatment Planning System
K171086 · Accuray Incorporated · Jun 2017
TrueBeam-TrueBeam STx-Edge
K162472 · Varian Medical Systems, Inc. · Jan 2017
Varian High Energy Linear Accelerator
K162476 · Varian Medical Systems, Inc. · Dec 2016
iDMS Data Management System
K161144 · Accuray Incorporated · Jun 2016