Cleared Traditional

K081829 - CAPIMAGE (FDA 510(k) Clearance)

Class I Radiology device.

K081829 · Danish Diagnostic Development A/S · Radiology device
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Optimized for regulatory review, auditing and printing
Jul 2008
Decision
14d
Days
Class 1
Risk

K081829 is an FDA 510(k) clearance for the CAPIMAGE. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Danish Diagnostic Development A/S (Horsholm, DK). The FDA issued a Cleared decision on July 11, 2008 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - 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

Submission Details

510(k) Number K081829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2008
Decision Date July 11, 2008
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. Third-party reviewed.

Device Classification

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.