Cleared Traditional

POSICAM-HZ & POSICAM-HZL (K926206) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

View all Positron devices

Submission Details

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.

Device Classification

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 178
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K926206.
QUANTITATIVE HEART
K940236 · Siemens Medical Solutions USA, Inc. · May 1994
MAGELLAN
K940300 · GE Medical Systems · Mar 1994
GCA-7200A
K931297 · Toshiba America Medical Systems, In.C · Jul 1993
CORT-EX
K926133 · General Electric Co. · Jun 1993
MAXXUS
K924498 · GE Medical Systems · Dec 1992
ARGUS PET SYSTEM
K923309 · GE Medical Systems · Sep 1992