Cleared Traditional

K020300 - NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)

K020300 is an FDA 510(k) clearance for NORTHWESTERN GATED BLOOD POOL SPECT (NU..., manufactured by Syntermed, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K020300 · Syntermed, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
84d
Days
Class 2
Risk

K020300 is an FDA 510(k) clearance for the NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS). Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Syntermed, Inc. (Anaheim, US). The FDA issued a Cleared decision on April 23, 2002 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K020300

510(k) Number K020300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2002
Decision Date April 23, 2002
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
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 446
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K020300.
MPOWER, MODEL 712 SERIES
K022001 · Positron Corp. · Jul 2002
CARDIOSPECT D90/CARDIO CAM
K021823 · Nuclear Cardiology Systems, Inc. · Jun 2002
HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4
K021656 · Nuclear Diagnostics · Jun 2002
NEUROSPECTQUAD GAMMA CAMERA
K013353 · Nuclear Cardiology Systems, Inc. · Mar 2002
EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS
K014033 · Syntermed, Inc. · Feb 2002
BCC GAMMA CAMERA
K013667 · Is2 Research, Inc. · Jan 2002