Cleared Traditional

K926206 - POSICAM-HZ & POSICAM-HZL

K926206 is an FDA 510(k) clearance for POSICAM-HZ & POSICAM-HZL, manufactured by Positron. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K926206 · Positron · Radiology device
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Jul 1993
Decision
211d
Days
Class 2
Risk

K926206 is an FDA 510(k) clearance for the POSICAM-HZ & POSICAM-HZL. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Positron (Houston, US). The FDA issued a Cleared decision on July 8, 1993 after a review of 211 days - an extended review 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: 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.

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FDA 510(k) Submission Details - K926206

510(k) Number K926206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1992
Decision Date July 08, 1993
Days to Decision 211 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 107d · This submission: 211d
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 248
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K926206.
MAGELLAN
K940300 · GE Medical Systems · Mar 1994
C-EQUAL(CEDERS-EMORY QUANTITIVE ANALYSIS)
K932745 · Adac Laboratories · Aug 1993
GCA-7200A
K931297 · Toshiba America Medical Systems, In.C · Jul 1993
CORT-EX
K926133 · General Electric Co. · Jun 1993
OPTITRACK
K924877 · Adac Laboratories · Dec 1992
MAXXUS
K924498 · GE Medical Systems · Dec 1992