Cleared Traditional

K843922 - OSTEON BONE MINERAL ANALYZER

K843922 is an FDA 510(k) clearance for OSTEON BONE MINERAL ANALYZER, manufactured by Osteon, Inc.. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K843922 · Osteon, Inc. · Radiology device
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Apr 1985
Decision
179d
Days
Class 2
Risk

K843922 is an FDA 510(k) clearance for the OSTEON BONE MINERAL ANALYZER. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Osteon, Inc. (Wahiawa, US). The FDA issued a Cleared decision on April 2, 1985 after a review of 179 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 Osteon, Inc. devices

FDA 510(k) Submission Details - K843922

510(k) Number K843922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1984
Decision Date April 02, 1985
Days to Decision 179 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 107d · This submission: 179d
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.