Cleared Traditional

GRIFFIN SPECT/CT IMAGING SYSTEM (K041218) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K041218 · Adac Laboratories · Radiology device
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May 2004
Decision
14d
Days
Class 2
Risk

K041218 is an FDA 510(k) clearance for the GRIFFIN SPECT/CT IMAGING SYSTEM. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Adac Laboratories (Milpitas, US). The FDA issued a Cleared decision on May 24, 2004 after a review of 14 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.

View all Adac Laboratories devices

Submission Details

510(k) Number K041218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2004
Decision Date May 24, 2004
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 166
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K041218.
DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION
K042257 · General Electric Co. · Sep 2004
GEMINI PET/CT IMAGING SYSTEM
K041955 · Philips Medical Systems (Cleveland), Inc. · Jul 2004
GE DISCOVERY ST SYSTEM
K041220 · GE Medical Systems · Jun 2004
SIEMENS ENHANCED IMAGING SYSTEM
K041166 · Siemens Medical Solutions USA, Inc. · May 2004
MODIFICATION TO GE DISCOVERY LS SYSTEM
K040172 · GE Medical Systems · Apr 2004
ALLEGRO IMAGING SYSTEM
K033782 · Philips Medical Systems (Cleveland), Inc. · Dec 2003