Cleared Traditional

K913012 - DIGITAL FLUORO STORE(DFS) W/NUMERICAL S...

K913012 is an FDA 510(k) clearance for DIGITAL FLUORO STORE(DFS) W/NUMERICAL S..., manufactured by Eigen. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K913012 · Eigen · Radiology device
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Sep 1991
Decision
77d
Days
Class 2
Risk

K913012 is an FDA 510(k) clearance for the DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Eigen (Nevada City, US). The FDA issued a Cleared decision on September 23, 1991 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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.

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FDA 510(k) Submission Details - K913012

510(k) Number K913012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1991
Decision Date September 23, 1991
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 107d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 150
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