Cleared Traditional

K861233 - DUAL PHOTON BONE DENSITOMETER (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K861233 · Medical and Scientific Enterprises, Inc. · Radiology device
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Mar 1987
Decision
336d
Days
Class 2
Risk

K861233 is an FDA 510(k) clearance for the DUAL PHOTON BONE DENSITOMETER. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Medical and Scientific Enterprises, Inc. (Concord, US). The FDA issued a Cleared decision on March 3, 1987 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medical and Scientific Enterprises, Inc. devices

Submission Details

510(k) Number K861233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1986
Decision Date March 03, 1987
Days to Decision 336 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
229d slower than avg
Panel avg: 107d · This submission: 336d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 146
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