Cleared Traditional

K033550 - DXL CALSCAN

K033550 is an FDA 510(k) clearance for DXL CALSCAN, manufactured by Demetech AB. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K033550 · Demetech AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
175d
Days
Class 2
Risk

K033550 is an FDA 510(k) clearance for the DXL CALSCAN. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Demetech AB (Solna, SE). The FDA issued a Cleared decision on May 5, 2004 after a review of 175 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1170 - 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.

View all Demetech AB devices

FDA 510(k) Submission Details - K033550

510(k) Number K033550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2003
Decision Date May 05, 2004
Days to Decision 175 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 107d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KGI Device Classification - Class 2, Special Controls

Product Code KGI Densitometer, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1170
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 - KGI Densitometer, Bone

All 88
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K033550.
IVA (MXA II SOFTWARE OPTION)
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INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS
K042480 · Hologic, Inc. · Oct 2004
PEDIATRIC REFERENCE DATABASE
K041266 · Hologic, Inc. · Aug 2004
HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
K033224 · Hologic, Inc. · Nov 2003
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
K023398 · Hologic, Inc. · Nov 2002
HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER
K002711 · Hologic, Inc. · Sep 2000