Cleared Traditional

K941362 - BONE MINERAL DENSITOMETER

K941362 is an FDA 510(k) clearance for BONE MINERAL DENSITOMETER, manufactured by Hologic, Inc.. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 527-day FDA review.

K941362 · Hologic, Inc. · Radiology device
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Aug 1995
Decision
527d
Days
Class 2
Risk

K941362 is an FDA 510(k) clearance for the BONE MINERAL DENSITOMETER. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Hologic, Inc. (Waltham, US). The FDA issued a Cleared decision on August 30, 1995 after a review of 527 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Hologic, Inc. devices

FDA 510(k) Submission Details - K941362

510(k) Number K941362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1994
Decision Date August 30, 1995
Days to Decision 527 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
420d slower than avg
Panel avg: 107d · This submission: 527d
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 44
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K941362.
FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
K983028 · Hologic, Inc. · Nov 1998
BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS
K961787 · Hologic, Inc. · Jun 1997
HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS
K963363 · Hologic, Inc. · Nov 1996
HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER
K943505 · Hologic, Inc. · Jan 1995
DTX-100
K926300 · Hologic, Inc. · Jul 1993
HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER
K913321 · Hologic, Inc. · Nov 1991