Cleared Traditional

K802206 - OMNI SCANNER CT 6000

K802206 is an FDA 510(k) clearance for OMNI SCANNER CT 6000, manufactured by Omnimedical. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K802206 · Omnimedical · Radiology device
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Oct 1980
Decision
42d
Days
Class 2
Risk

K802206 is an FDA 510(k) clearance for the OMNI SCANNER CT 6000. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Omnimedical (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 42 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 Omnimedical devices

FDA 510(k) Submission Details - K802206

510(k) Number K802206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1980
Decision Date October 23, 1980
Days to Decision 42 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 107d · This submission: 42d
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 761
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K802206.
DEHYDRATED BILE
K811358 · Acumedia Manufacturers, Inc. · May 1981
SCANNER, COMPUTERIZED TOMOGRAPHIC
K803181 · General Electric Co. · Jan 1981
G.E. SCAN CAPABILITY CAT.#B7815F
K802045 · General Electric Co. · Oct 1980
SYNERVIEW MODEL 6545
K801407 · Philips Medical Systems (Cleveland), Inc. · Jul 1980
ACTA-SCANNER 0220FS
K791153 · Pfizer, Inc. · Aug 1979
PFIZER 0200FS LOCALLZER
K791163 · Pfizer, Inc. · Aug 1979