Cleared Traditional

K140206 - SCINTILLATION GAMMA CAMERA

K140206 is an FDA 510(k) clearance for SCINTILLATION GAMMA CAMERA, manufactured by Ddd-Diagnostic A/S. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K140206 · Ddd-Diagnostic A/S · Radiology device
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May 2014
Decision
101d
Days
Class 2
Risk

K140206 is an FDA 510(k) clearance for the SCINTILLATION GAMMA CAMERA. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ddd-Diagnostic A/S (Denmark, DK). The FDA issued a Cleared decision on May 8, 2014 after a review of 101 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.

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FDA 510(k) Submission Details - K140206

510(k) Number K140206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2014
Decision Date May 08, 2014
Days to Decision 101 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
6d faster than avg
Panel avg: 107d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 269
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K140206.
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