Cleared Traditional

K983724 - ORCA-DX BONE DENSITOMETER

K983724 is an FDA 510(k) clearance for ORCA-DX BONE DENSITOMETER, manufactured by Lunar Corp.. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K983724 · Lunar Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
47d
Days
Class 2
Risk

K983724 is an FDA 510(k) clearance for the ORCA-DX BONE DENSITOMETER. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Lunar Corp. (Madison, US). The FDA issued a Cleared decision on December 8, 1998 after a review of 47 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. 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 Lunar Corp. devices

FDA 510(k) Submission Details - K983724

510(k) Number K983724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1998
Decision Date December 08, 1998
Days to Decision 47 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
60d faster than avg
Panel avg: 107d · This submission: 47d
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 64
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K983724.
OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
K992775 · Hologic, Inc. · Oct 1999
EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
K992677 · Hologic, Inc. · Sep 1999
PRODIGY TOTAL BODY SOFTWARE
K983564 · Lunar Corp. · Dec 1998
FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS
K983262 · Lunar Corp. · Nov 1998
FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER
K983269 · Lunar Corp. · Nov 1998
FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS
K983271 · Lunar Corp. · Nov 1998