Cleared Traditional

K913078 - LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET

K913078 is an FDA 510(k) clearance for LATERAL SPINE OPT. XR-SERIES X-RAY BONE..., manufactured by Norland Corp.. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K913078 · Norland Corp. · Radiology device
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Sep 1991
Decision
75d
Days
Class 2
Risk

K913078 is an FDA 510(k) clearance for the LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Norland Corp. (Fort Atkinson, US). The FDA issued a Cleared decision on September 24, 1991 after a review of 75 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Norland Corp. devices

FDA 510(k) Submission Details - K913078

510(k) Number K913078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1991
Decision Date September 24, 1991
Days to Decision 75 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 107d · This submission: 75d
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 70
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K913078.
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
QDR-1000 AND QDR-1000/W X-RAY BONE DENSITOMETER
K905753 · Hologic, Inc. · Jun 1991
QDR-1000 AND WITH X-RAY BONE DENSITOMETER
K905691 · Hologic, Inc. · May 1991
HOLOGIC QDR-1000/W X-RAY BONE DENSITOMETER
K894795 · Hologic, Inc. · Aug 1990