Cleared Special

K060895 - NOMOSSTAT

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
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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

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

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