Cleared Traditional

K060111 - IVA (MXA II SOFTWARE OPTION)

K060111 is an FDA 510(k) clearance for IVA (MXA II SOFTWARE OPTION), manufactured by Hologic, Inc.. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K060111 · Hologic, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
97d
Days
Class 2
Risk

K060111 is an FDA 510(k) clearance for the IVA (MXA II SOFTWARE OPTION). Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Hologic, Inc. (Bedford, US). The FDA issued a Cleared decision on April 24, 2006 after a review of 97 days - within the typical 510(k) review window.

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 Hologic, Inc. devices

FDA 510(k) Submission Details - K060111

510(k) Number K060111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2006
Decision Date April 24, 2006
Days to Decision 97 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
10d faster than avg
Panel avg: 107d · This submission: 97d
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 95
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K060111.
GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT
K072439 · Ge Medical Systems Ultrasound and Primary Care Dia · Sep 2007
GE LUNAR BODY COMPOSITION SOFTWARE
K071570 · Ge Medical Systems Lunar · Jun 2007
HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS
K061561 · Hologic, Inc. · Jul 2006
LUNAR IDXA
K052581 · Ge Medical Systems Ultrasound and Primary Care Dia · Oct 2005
INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS
K042480 · Hologic, Inc. · Oct 2004
PEDIATRIC REFERENCE DATABASE
K041266 · Hologic, Inc. · Aug 2004