Cleared Traditional

K132092 - ESTEYA

K132092 is an FDA 510(k) clearance for ESTEYA, manufactured by Nucletron B.V.. The device is a Class 2 Radiology device with product code JAD cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K132092 · Nucletron B.V. · Radiology device
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Sep 2013
Decision
83d
Days
Class 2
Risk

K132092 is an FDA 510(k) clearance for the ESTEYA. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Nucletron B.V. (Rice Lake, US). The FDA issued a Cleared decision on September 26, 2013 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - 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 Nucletron B.V. devices

FDA 510(k) Submission Details - K132092

510(k) Number K132092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2013
Decision Date September 26, 2013
Days to Decision 83 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
24d faster than avg
Panel avg: 107d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAD Device Classification - Class 2, Special Controls

Product Code JAD System, Therapeutic, X-ray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5900
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 - JAD System, Therapeutic, X-ray

All 40
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