Cleared Traditional

K980569 - FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS

K980569 is an FDA 510(k) clearance for FRACTURE RISK ASSESSMENT CAPABILITY FOR..., 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 119-day FDA review.

K980569 · Norland Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
119d
Days
Class 2
Risk

K980569 is an FDA 510(k) clearance for the FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS. 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 June 12, 1998 after a review of 119 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K980569

510(k) Number K980569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1998
Decision Date June 12, 1998
Days to Decision 119 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
12d slower than avg
Panel avg: 107d · This submission: 119d
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 124
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K980569.
XCT 2000 L PQCT BONE DENSITOMETER
K983273 · Medical Systems, Inc. · Oct 1998
DPX-RX BONE DENSITOMETER
K982267 · Lunar Corp. · Aug 1998
FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER
K980289 · Norland Corp. · Jun 1998
ACCUDEXA BONE DENSITOMETER
K981124 · Schick Technologies, Inc. · Jun 1998
REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER
K980125 · Norland Corp. · May 1998
NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS
K973459 · Norland Corp. · Feb 1998
K980569 · FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS
Download PDF FDA Summary Norland Corp.