Cleared Traditional

K092019 - MODEL 1014 PC ELECTROMETER

K092019 is an FDA 510(k) clearance for MODEL 1014 PC ELECTROMETER, manufactured by Sun Nuclear Corp.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K092019 · Sun Nuclear Corp. · Radiology device
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Sep 2009
Decision
71d
Days
Class 2
Risk

K092019 is an FDA 510(k) clearance for the MODEL 1014 PC ELECTROMETER. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Sun Nuclear Corp. (Melbourne, US). The FDA issued a Cleared decision on September 15, 2009 after a review of 71 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sun Nuclear Corp. devices

FDA 510(k) Submission Details - K092019

510(k) Number K092019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2009
Decision Date September 15, 2009
Days to Decision 71 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
36d faster than avg
Panel avg: 107d · This submission: 71d
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 370
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