Cleared Traditional

K864299 - NOVO BMC-LAB 23, BONE DENSITOMETER

K864299 is an FDA 510(k) clearance for NOVO BMC-LAB 23, manufactured by Scan Detectronic Laboratories, Inc.. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 377-day FDA review.

K864299 · Scan Detectronic Laboratories, Inc. · Radiology device
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Nov 1987
Decision
377d
Days
Class 2
Risk

K864299 is an FDA 510(k) clearance for the NOVO BMC-LAB 23, BONE DENSITOMETER. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Scan Detectronic Laboratories, Inc. (New Milford, US). The FDA issued a Cleared decision on November 12, 1987 after a review of 377 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 Scan Detectronic Laboratories, Inc. devices

FDA 510(k) Submission Details - K864299

510(k) Number K864299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1986
Decision Date November 12, 1987
Days to Decision 377 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
270d slower than avg
Panel avg: 107d · This submission: 377d
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 104
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K864299.
MODIFIED QDR-1000 X-RAY BONE DENSITOMETER
K890999 · Hologic, Inc. · Dec 1989
HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED
K883280 · Hologic, Inc. · Sep 1988
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
BONE MINERAL DENSITOMETRY OPTION B7918AA
K863618 · General Electric Co. · Mar 1987