Cleared Traditional

K952109 - IP500 NUCLEAR GAMMA CAMERA SYSTEM

K952109 is the FDA 510(k) clearance for IP500 NUCLEAR GAMMA CAMERA SYSTEM 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 110-day FDA review.

K952109 · Siemens Medical Solutions USA, Inc. · Radiology device
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Aug 1995
Decision
110d
Days
Class 2
Risk

K952109 is an FDA 510(k) clearance for the IP500 NUCLEAR GAMMA CAMERA SYSTEM. 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 August 23, 1995 after a review of 110 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 K952109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1995
Decision Date August 23, 1995
Days to Decision 110 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
3d slower than avg
Panel avg: 107d · This submission: 110d
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 K952109.
INSPECT/PROSPECT
K952564 · Adac Laboratories · Nov 1995
VARICAM
K953801 · Elscint, Inc. · Nov 1995
TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA
K952674 · Elscint, Inc. · Sep 1995
PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMS
K951144 · GE Medical Systems · Jul 1995
VANTAGE, FOR ADAC GAMMA CAMERAS
K943596 · Adac Laboratories · Apr 1995
ATTENUATION CORRECTION
K945652 · GE Medical Systems · Mar 1995