Cleared Special

K060895 - NOMOSSTAT, VERSION 1.0

K060895 is an FDA 510(k) clearance for NOMOSSTAT, manufactured by Nomos Corp.. The device is a Class 2 Radiology device with product code IYE cleared through the Special 510(k) pathway after a 109-day FDA review.

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.

FDA 510(k) Submission Details - K060895

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 107d · This submission: 109d
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 677
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K060895.
TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT
K062618 · Varian Medical Systems, Inc. · Sep 2006
IGUIDE SYSTEM
K062611 · Medical Intelligence Medizintechnik-GmbH-An Elekta · Sep 2006
CALYPSO 4D LOCALIZATION SYSTEM
K060906 · Calypso Medical Technologies, Inc. · Jul 2006
MAGIS1
K061713 · Direx Systems Corp. · Jul 2006
TRILOGY RADIOTHERAPY DELIVERY SYSTEM
K061140 · Varian Medical Systems · May 2006
COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0
K060633 · Siemens Medical Solutions USA, Inc. · May 2006