Cleared Traditional

K993176 - MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY

K993176 is an FDA 510(k) clearance for MULTI-RACIAL REFERENCE POPULATION FOR P..., manufactured by Norland Medical Systems, Inc.. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K993176 · Norland Medical Systems, Inc. · Radiology device
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Jun 2000
Decision
272d
Days
Class 2
Risk

K993176 is an FDA 510(k) clearance for the MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Norland Medical Systems, Inc. (Fort Atkinson, US). The FDA issued a Cleared decision on June 20, 2000 after a review of 272 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 Norland Medical Systems, Inc. devices

FDA 510(k) Submission Details - K993176

510(k) Number K993176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1999
Decision Date June 20, 2000
Days to Decision 272 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 107d · This submission: 272d
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 86
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K993176.
HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER
K002711 · Hologic, Inc. · Sep 2000
PEDIATRIC REFERENCE DATA
K001812 · Lunar Corp. · Jul 2000
LUNAR REPORT GENERATOR II
K001756 · Lunar Corp. · Jul 2000
APOLLO MULTI-RACIAL REFERENCE POPULATION
K993337 · Norland Medical Systems, Inc. · May 2000
PRODIGY LATERAL VIEW SOFTWARE
K000826 · Lunar Corp. · Apr 2000
XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46
K992125 · Norland Medical Systems, Inc. · Nov 1999