Cleared Traditional

K843366 - SUPERPETT

K843366 is an FDA 510(k) clearance for SUPERPETT, manufactured by Scanditronix, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K843366 · Scanditronix, Inc. · Radiology device
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Nov 1984
Decision
85d
Days
Class 2
Risk

K843366 is an FDA 510(k) clearance for the SUPERPETT. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Scanditronix, Inc. (Newburyport, US). The FDA issued a Cleared decision on November 21, 1984 after a review of 85 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 Scanditronix, Inc. devices

FDA 510(k) Submission Details - K843366

510(k) Number K843366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1984
Decision Date November 21, 1984
Days to Decision 85 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 107d · This submission: 85d
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.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 392
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K843366.
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ADAC TOMOGRAPHY OPTION
K791055 · Adac Laboratories · Sep 1979
RADIONUCLIDE COMPUTED TOMOGRAPHY SYS.
K770220 · G.D. Searle and Co. · Feb 1977