Cleared Traditional

K852239 - POSICAM TM(MODEL 3.2,4.3,6.5)

K852239 is an FDA 510(k) clearance for POSICAM TM(MODEL 3.2, manufactured by Position Corp.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K852239 · Position Corp. · Radiology device
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Sep 1985
Decision
103d
Days
Class 2
Risk

K852239 is an FDA 510(k) clearance for the POSICAM TM(MODEL 3.2,4.3,6.5). Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Position Corp. (Fort Worth, US). The FDA issued a Cleared decision on September 3, 1985 after a review of 103 days - within the typical 510(k) review window.

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: 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 Position Corp. devices

FDA 510(k) Submission Details - K852239

510(k) Number K852239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1985
Decision Date September 03, 1985
Days to Decision 103 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 107d · This submission: 103d
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 397
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K852239.
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NON-CIRCULAR ORBITING OPTION
K861252 · Siemens Gammasonics, Inc. · Apr 1986
GE RT/PLAN MAGNETIC TAPE DRIVE OPTION
K802801 · General Electric Co. · Jan 1981
ADAC TOMOGRAPHY OPTION
K791055 · Adac Laboratories · Sep 1979
RADIONUCLIDE COMPUTED TOMOGRAPHY SYS.
K770220 · G.D. Searle and Co. · Feb 1977