Cleared Traditional

K925330 - SYSTEM, TOMOGRAPHIC, NUCLEAR

K925330 is an FDA 510(k) clearance for SYSTEM, manufactured by Rjl Associates, LLC. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K925330 · Rjl Associates, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
99d
Days
Class 2
Risk

K925330 is an FDA 510(k) clearance for the SYSTEM, TOMOGRAPHIC, NUCLEAR. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Rjl Associates, LLC (East Lyme, US). The FDA issued a Cleared decision on January 28, 1993 after a review of 99 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.

FDA 510(k) Submission Details - K925330

510(k) Number K925330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1992
Decision Date January 28, 1993
Days to Decision 99 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
8d faster than avg
Panel avg: 107d · This submission: 99d
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 472
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K925330.
SIM-400 SYSTEM
K931193 · Scinticor, Inc. · Jun 1993
CORT-EX
K926133 · General Electric Co. · Jun 1993
PENN-PET SCANNER
K930428 · Ugm Medical Systems, Inc. · Jun 1993
EQUILIBRIUM RADIONUCLIDE ANGIOCARDIORAPHY ANALYSIS
K925186 · Strichman Medical Equipment, Inc. · Jan 1993
M-LINK
K922303 · Medimage, Inc. · Dec 1992
OPTITRACK
K924877 · Adac Laboratories · Dec 1992
K925330 · SYSTEM, TOMOGRAPHIC, NUCLEAR
Download PDF FDA Summary Rjl Associates, LLC