Cleared Traditional

K093640 - DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K093640 · Electron Jsco. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
521d
Days
Class 2
Risk

K093640 is an FDA 510(k) clearance for the DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA. Classified as System, Imaging, X-ray, Electrostatic (product code IXK), Class II - Special Controls.

Submitted by Electron Jsco. (Great Neck, US). The FDA issued a Cleared decision on April 29, 2011 after a review of 521 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1630 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Electron Jsco. devices

Submission Details

510(k) Number K093640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2009
Decision Date April 29, 2011
Days to Decision 521 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
414d slower than avg
Panel avg: 107d · This submission: 521d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IXK System, Imaging, X-ray, Electrostatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1630
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.