Cleared Special

HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY (K023398) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K023398 · Hologic, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
30d
Days
Class 2
Risk

K023398 is an FDA 510(k) clearance for the HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Hologic, Inc. (Bedford, US). The FDA issued a Cleared decision on November 8, 2002 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1170 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hologic, Inc. devices

Submission Details

510(k) Number K023398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2002
Decision Date November 08, 2002
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 11
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K023398.
GEHC DXA Bone Densitometers with enCORE version 18
K191112 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Sep 2019
Aria
K180782 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Apr 2018
GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION
K082317 · General Electric Co. · Sep 2008
BONE MINERAL DENSITOMETRY OPTION B7918AA
K863618 · General Electric Co. · Mar 1987