Cleared Traditional

K000826 - PRODIGY LATERAL VIEW SOFTWARE

K000826 is an FDA 510(k) clearance for PRODIGY LATERAL VIEW SOFTWARE, 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 31-day FDA review.

K000826 · Lunar Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
31d
Days
Class 2
Risk

K000826 is an FDA 510(k) clearance for the PRODIGY LATERAL VIEW SOFTWARE. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Lunar Corp. (Madison, US). The FDA issued a Cleared decision on April 14, 2000 after a review of 31 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 - K000826

510(k) Number K000826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2000
Decision Date April 14, 2000
Days to Decision 31 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
76d faster than avg
Panel avg: 107d · This submission: 31d
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 108
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K000826.
MODIFICATION TO ACCUDEXA BONE DENSITOMETER
K001429 · Schick Technologies, Inc. · May 2000
APOLLO MULTI-RACIAL REFERENCE POPULATION
K993337 · Norland Medical Systems, Inc. · May 2000
METRISCAN BONE DENSITY SYSTEM
K000162 · Alara, Inc. · May 2000
XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46
K992125 · Norland Medical Systems, Inc. · Nov 1999
OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
K992775 · Hologic, Inc. · Oct 1999
QCT BONE MINERAL ANALYSIS SOFTWARE
K992246 · Image Analysis, Inc. · Sep 1999