Cleared Traditional

K861515 - OSTEOPAK BMD (BONE MINERAL DENSITOMETER)

K861515 is an FDA 510(k) clearance for OSTEOPAK BMD (BONE MINERAL DENSITOMETER), manufactured by Siemens Gammasonics, Inc.. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 285-day FDA review.

K861515 · Siemens Gammasonics, Inc. · Radiology device
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Feb 1987
Decision
285d
Days
Class 2
Risk

K861515 is an FDA 510(k) clearance for the OSTEOPAK BMD (BONE MINERAL DENSITOMETER). Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Siemens Gammasonics, Inc. (Des Plaines, US). The FDA issued a Cleared decision on February 2, 1987 after a review of 285 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 Siemens Gammasonics, Inc. devices

FDA 510(k) Submission Details - K861515

510(k) Number K861515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1986
Decision Date February 02, 1987
Days to Decision 285 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
178d slower than avg
Panel avg: 107d · This submission: 285d
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.