Cleared Traditional

K942146 - PHOENIX NUCLEAR MEDICINE PROCESSING COM...

K942146 is the FDA 510(k) clearance for PHOENIX NUCLEAR MEDICINE PROCESSING COM... by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K942146 · Siemens Medical Solutions USA, Inc. · Radiology device
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Sep 1994
Decision
143d
Days
Class 2
Risk

K942146 is an FDA 510(k) clearance for the PHOENIX NUCLEAR MEDICINE PROCESSING COMPUTER. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Hoffman Estates, US). The FDA issued a Cleared decision on September 23, 1994 after a review of 143 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K942146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1994
Decision Date September 23, 1994
Days to Decision 143 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 107d · This submission: 143d
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 242
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K942146.
NON-UNIFORM ATTENUATION CORRECTION SYSTEM
K942145 · Siemens Medical Solutions USA, Inc. · Feb 1995
ADVANCE ANALYSIS SOFTWARE
K941223 · General Electric Co. · Nov 1994
PATLAK & FDG AUTORADIOGRAPHIC
K936001 · GE Medical Systems · Sep 1994
SNAC (SIEMENS NUCLEAR ACQUISITION COMPUTER)
K942116 · Siemens Corp. · Jul 1994
QUANTITATIVE HEART
K940236 · Siemens Medical Solutions USA, Inc. · May 1994
MAGELLAN
K940300 · GE Medical Systems · Mar 1994