Cleared Traditional

K885322 - 3D/DENTAL

K885322 is an FDA 510(k) clearance for 3D/DENTAL, manufactured by Columbia Scientific, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K885322 · Columbia Scientific, Inc. · Radiology device
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Feb 1989
Decision
43d
Days
Class 2
Risk

K885322 is an FDA 510(k) clearance for the 3D/DENTAL. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Columbia Scientific, Inc. (Columbia, US). The FDA issued a Cleared decision on February 9, 1989 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 Columbia Scientific, Inc. devices

FDA 510(k) Submission Details - K885322

510(k) Number K885322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1988
Decision Date February 09, 1989
Days to Decision 43 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 107d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 710
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