Cleared Traditional

OPTIMA NM/CT 640 (K121019) - FDA 510(k) Clearance

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

K121019 · Ge Healthcare · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
15d
Days
Class 2
Risk

K121019 is an FDA 510(k) clearance for the OPTIMA NM/CT 640. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ge Healthcare (Tirat Hacarmel, IL). The FDA issued a Cleared decision on April 19, 2012 after a review of 15 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 Ge Healthcare devices

Submission Details

510(k) Number K121019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2012
Decision Date April 19, 2012
Days to Decision 15 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
92d faster than avg
Panel avg: 107d · This submission: 15d
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 148
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