Cleared Traditional

K042875 - NAVIGATOR

K042875 is an FDA 510(k) clearance for NAVIGATOR, manufactured by Nomos Corp.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K042875 · Nomos Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
256d
Days
Class 2
Risk

K042875 is an FDA 510(k) clearance for the NAVIGATOR. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Nomos Corp. (Cranberry Township, US). The FDA issued a Cleared decision on July 1, 2005 after a review of 256 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 Nomos Corp. devices

FDA 510(k) Submission Details - K042875

510(k) Number K042875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2004
Decision Date July 01, 2005
Days to Decision 256 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
149d slower than avg
Panel avg: 107d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 366
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K042875.
FRAMELESS RADIOSURGERY COMPONENTS
K053500 · Brainlab AG · Feb 2006
VISION (WITH OFF-LINE REVIEW)
K052391 · Varian Medical Systems · Nov 2005
IPLAN RT FIBERTRACKING
K052220 · Brainlab AG · Sep 2005
ACCUCHANGER
K043409 · Direx Systems Corp. · May 2005
4D INTEGRATED TREATMENT CONSOLE
K050479 · Varian Medical Systems · Mar 2005
MILLENNIUM MULTI-LEAF COLLIMATOR
K050442 · Varian Medical Systems · Mar 2005