Cleared Traditional

K974619 - SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM (FDA 510(k) Clearance)

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

K974619 · Afp Imaging Corp. · Radiology device
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Feb 1998
Decision
76d
Days
Class 2
Risk

K974619 is an FDA 510(k) clearance for the SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Afp Imaging Corp. (North Attleboro, US). The FDA issued a Cleared decision on February 25, 1998 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2030 - 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 Afp Imaging Corp. devices

Submission Details

510(k) Number K974619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1997
Decision Date February 25, 1998
Days to Decision 76 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
31d faster than avg
Panel avg: 107d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LMA Digitizer, Image, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2030
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.