Cleared Traditional

K870513 - CSI/3D

K870513 is an FDA 510(k) clearance for CSI/3D, 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 92-day FDA review.

K870513 · Columbia Scientific, Inc. · Radiology device
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May 1987
Decision
92d
Days
Class 2
Risk

K870513 is an FDA 510(k) clearance for the CSI/3D. 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 May 8, 1987 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Columbia Scientific, Inc. devices

FDA 510(k) Submission Details - K870513

510(k) Number K870513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1987
Decision Date May 08, 1987
Days to Decision 92 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 107d · This submission: 92d
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
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K870513.
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-2000T-11
K874767 · Shimadzu Precision Instruments, Inc. · Feb 1988
CT PACE CATALOG NUMBER B7950A
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CT9800 QUICK 3D #B7919DA
K871859 · General Electric Co. · Aug 1987
TOSHIBA TCT-600 COMPUTED TOMOGRAPHY (CT) X-RAY
K863935 · Toshiba Medical Systems · Dec 1986
CT MAX, CATALOG NO. B7940 HA
K862317 · General Electric Co. · Oct 1986
SOLID STATE DETECTOR COMPUTERIZED TOMOGRAPHIC
K861708 · General Electric Co. · Aug 1986