Cleared Traditional

K863618 - BONE MINERAL DENSITOMETRY OPTION B7918AA

K863618 is the FDA 510(k) clearance for BONE MINERAL DENSITOMETRY OPTION B7918AA by General Electric Co.. It is a Class 2 Radiology device (product code KGI) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K863618 · General Electric Co. · Radiology device
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Mar 1987
Decision
174d
Days
Class 2
Risk

K863618 is an FDA 510(k) clearance for the BONE MINERAL DENSITOMETRY OPTION B7918AA. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on March 9, 1987 after a review of 174 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 General Electric Co. devices

Submission Details

510(k) Number K863618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1986
Decision Date March 09, 1987
Days to Decision 174 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 107d · This submission: 174d
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 44
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K863618.
HOLOGIC MODEL WHF-1 ANTHROPOMORPHIC FEMUR PHANTOM
K883360 · Hologic, Inc. · Sep 1988
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
OSTEOPAK BMD (BONE MINERAL DENSITOMETER)
K861515 · Siemens Gammasonics, Inc. · Feb 1987