Cleared Traditional

K781753 - TOMOGSCANNER 2

K781753 is an FDA 510(k) clearance for TOMOGSCANNER 2, manufactured by Tomogscanner OK , Ltd.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K781753 · Tomogscanner OK , Ltd. · Radiology device
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Nov 1978
Decision
17d
Days
Class 2
Risk

K781753 is an FDA 510(k) clearance for the TOMOGSCANNER 2. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Tomogscanner OK , Ltd. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1978 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 Tomogscanner OK , Ltd. devices

FDA 510(k) Submission Details - K781753

510(k) Number K781753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1978
Decision Date November 03, 1978
Days to Decision 17 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 107d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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.