Cleared Traditional

K813162 - INTERAD WHOLE BODY CT SCANNER

K813162 is an FDA 510(k) clearance for INTERAD WHOLE BODY CT SCANNER, manufactured by Interad Systems, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K813162 · Interad Systems, Inc. · Radiology device
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Dec 1981
Decision
34d
Days
Class 2
Risk

K813162 is an FDA 510(k) clearance for the INTERAD WHOLE BODY CT SCANNER. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Interad Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 14, 1981 after a review of 34 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 Interad Systems, Inc. devices

FDA 510(k) Submission Details - K813162

510(k) Number K813162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1981
Decision Date December 14, 1981
Days to Decision 34 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 107d · This submission: 34d
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 760
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K813162.
CENTAURI CT SCANNER
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K820688 · General Electric Co. · Mar 1982
IMAGE ANALYSIS CENTER
K813196 · Technicare Corp. · Dec 1981
CT/T 8800
K812509 · General Electric Co. · Oct 1981
DELTASCAN 2060 CT SCANNER
K812410 · Technicare Corp. · Oct 1981
CT/T 9800
K812241 · General Electric Co. · Sep 1981