Cleared Traditional

K081829 - CAPIMAGE

K081829 is an FDA 510(k) clearance for CAPIMAGE, manufactured by Danish Diagnostic Development A/S. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K081829 · Danish Diagnostic Development A/S · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K081829

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
Combination Product No
PCCP Authorized No
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.

IYX Device Classification - Class 1, General Controls

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.

Regulatory Consultant

Underwriters Laboratories, Inc.
CASEY CONRY

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 109
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K081829.
GAMMALOC SYSTEM, MODEL 03-00001
K082588 · Dilon Technologies, LLC · Dec 2009
MODEL SENTINELLA 102
K092471 · General Equipment For Medical Imaging, S.A. · Oct 2009
VERISTA IMAGING ISOCAM II GAMMA CAMERA
K081757 · Verista Imaging, Inc. · Aug 2008
T-QUEST SYSTEM
K073456 · Medx, Inc. · Dec 2007
KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5
K071195 · Ani-Kal Ii, LLC · Jun 2007
MAMMOPAD RADIOLUCENT CUSHION
K062141 · Biolucent, Inc. · Sep 2006
K081829 · CAPIMAGE
Download PDF FDA Summary Danish Diagnostic Dev…