Cleared Traditional

K120668 - SENTINEL

K120668 is the FDA 510(k) clearance for SENTINEL by C-Rad Positioning AB. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K120668 · C-Rad Positioning AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
147d
Days
Class 2
Risk

K120668 is an FDA 510(k) clearance for the SENTINEL. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by C-Rad Positioning AB (Uppsala, SE). The FDA issued a Cleared decision on July 30, 2012 after a review of 147 days - within the typical 510(k) review window.

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 C-Rad Positioning AB devices

Submission Details

510(k) Number K120668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2012
Decision Date July 30, 2012
Days to Decision 147 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 107d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 313
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K120668.
CALYPSO SYSTEM
K123137 · Varian Medical Systems · Dec 2012
EXACTRAC VERO
K122451 · Brainlab AG · Sep 2012
EXACTRAC X-RAY X-RAY
K120789 · Brainlab AG · Aug 2012
ARTISTETM SOLUTION WITH SYS VCIO
K121295 · Siemens Medical Solutions USA, Inc. · Jun 2012
VOLUSON E6/E8/E8EXPERT/E10
K113758 · Ge Healthcare · Jan 2012
SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING
K112778 · Varian Medical Systems · Dec 2011