Cleared Traditional

K945261 - PRISM 1500XP NUCLEAR GAMMA CAMERA SYSTEM

K945261 is an FDA 510(k) clearance for PRISM 1500XP NUCLEAR GAMMA CAMERA SYSTEM, manufactured by Ohio Imaging, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K945261 · Ohio Imaging, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
144d
Days
Class 2
Risk

K945261 is an FDA 510(k) clearance for the PRISM 1500XP NUCLEAR GAMMA CAMERA SYSTEM. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ohio Imaging, Inc. (Cleveland, US). The FDA issued a Cleared decision on March 21, 1995 after a review of 144 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 Ohio Imaging, Inc. devices

FDA 510(k) Submission Details - K945261

510(k) Number K945261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1994
Decision Date March 21, 1995
Days to Decision 144 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 107d · This submission: 144d
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 391
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K945261.
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
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