Cleared Traditional

K861233 - DUAL PHOTON BONE DENSITOMETER

K861233 is an FDA 510(k) clearance for DUAL PHOTON BONE DENSITOMETER, manufactured by Medical and Scientific Enterprises, Inc.. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K861233 · Medical and Scientific Enterprises, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K861233

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.

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 45
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K861233.
HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1
K871446 · Hologic, Inc. · Oct 1987
X-CALIBER MODEL 1000 BONE MINERAL ANALYZER
K871553 · Hologic, Inc. · Oct 1987
BONE MINERAL DENSITOMETRY OPTION B7918AA
K863618 · General Electric Co. · Mar 1987
OSTEOPAK BMD (BONE MINERAL DENSITOMETER)
K861515 · Siemens Gammasonics, Inc. · Feb 1987