Cleared Traditional

K051460 - C.CAM-AC

K051460 is an FDA 510(k) clearance for C.CAM-AC, manufactured by Danish Diagnostic Development A/S. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K051460 · Danish Diagnostic Development A/S · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
12d
Days
Class 2
Risk

K051460 is an FDA 510(k) clearance for the C.CAM-AC. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Danish Diagnostic Development A/S (Horsholm, DK). The FDA issued a Cleared decision on June 15, 2005 after a review of 12 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 Danish Diagnostic Development A/S devices

FDA 510(k) Submission Details - K051460

510(k) Number K051460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2005
Decision Date June 15, 2005
Days to Decision 12 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
95d faster than avg
Panel avg: 107d · This submission: 12d
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 324
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K051460.
HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
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VENTRI
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CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
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PRECEDENCE SPECT/CT IMAGING SYSTEM
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GEMINI GXL
K051170 · Philips Medical Systems (Cleveland), Inc. · May 2005
LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I
K050509 · Cti Pet Systems, Inc. · Mar 2005