Cleared Special

NOMOSSTAT, VERSION 1.0 (K060895) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K060895 · Nomos Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
109d
Days
Class 2
Risk

K060895 is an FDA 510(k) clearance for the NOMOSSTAT, VERSION 1.0. 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 21, 2006 after a review of 109 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nomos Corp. devices

Submission Details

510(k) Number K060895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2006
Decision Date July 21, 2006
Days to Decision 109 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
2d slower than avg
Panel avg: 107d · This submission: 109d
Pathway characteristics
Modification to existing cleared device.

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 202
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K060895.
TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM
K070094 · Varian Medical Systems, Inc. · Feb 2007
RPM RESPIRATORY GATING SYSTEM
K063270 · Varian Medical Systems, Inc. · Dec 2006
TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT
K062618 · Varian Medical Systems, Inc. · Sep 2006
COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0
K060633 · Siemens Medical Solutions USA, Inc. · May 2006
ONCOR EXPRESSION
K060226 · Siemens Medical Solutions USA, Inc. · Mar 2006
VISION
K042956 · Varian Medical Systems, Inc. · Mar 2005