Cleared Traditional

K863618 - BONE MINERAL DENSITOMETRY OPTION B7918AA

K863618 is an FDA 510(k) clearance for BONE MINERAL DENSITOMETRY OPTION B7918AA, manufactured by General Electric Co.. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K863618

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.

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 95
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