Cleared Traditional

K011917 - ADVANCED HIP ASSESSMENT SOFTWARE

K011917 is an FDA 510(k) clearance for ADVANCED HIP ASSESSMENT SOFTWARE, manufactured by Ge Lunar Corp.. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K011917 · Ge Lunar Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
44d
Days
Class 2
Risk

K011917 is an FDA 510(k) clearance for the ADVANCED HIP ASSESSMENT SOFTWARE. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Ge Lunar Corp. (Madison, US). The FDA issued a Cleared decision on August 3, 2001 after a review of 44 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.

FDA 510(k) Submission Details - K011917

510(k) Number K011917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2001
Decision Date August 03, 2001
Days to Decision 44 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
63d faster than avg
Panel avg: 107d · This submission: 44d
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 144
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K011917.
SECTRA OSTEOPOROSIS PACKAGE
K021527 · Sectra-Imtec AB · Jun 2002
DEXACARE G4
K021331 · Osteometer Meditech, Inc. · May 2002
CTXA HIP
K002113 · Mindways Software, Inc. · Dec 2001
X-POSURE SYSTEM VERSION 2 MAMMO
K003656 · Pronosco A/S · Dec 2000
X-POSURE SYSTEM VERSION 2 RAD
K002500 · Pronosco A/S · Oct 2000
HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER
K002711 · Hologic, Inc. · Sep 2000
K011917 · ADVANCED HIP ASSESSMENT SOFTWARE
Download PDF FDA Summary Ge Lunar Corp.