Cleared Traditional

K922286 - MODEL XCT-900 PQCT X-RAY BONE DENSITOMETER

K922286 is an FDA 510(k) clearance for MODEL XCT-900 PQCT X-RAY BONE DENSITOMETER, 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 196-day FDA review.

K922286 · Norland Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
196d
Days
Class 2
Risk

K922286 is an FDA 510(k) clearance for the MODEL XCT-900 PQCT X-RAY BONE DENSITOMETER. 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 November 27, 1992 after a review of 196 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.

FDA 510(k) Submission Details - K922286

510(k) Number K922286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1992
Decision Date November 27, 1992
Days to Decision 196 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 107d · This submission: 196d
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 125
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K922286.
THE OSTEOREPORT
K934040 · Woodson and Associates, LLC · Sep 1994
FORARM OPT/NORLAND XR SERIES X-RAY BONE DENSITOMET
K926019 · Norland Corp. · Sep 1994
DTX-100
K926300 · Hologic, Inc. · Jul 1993
HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER
K913321 · Hologic, Inc. · Nov 1991
LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET
K913078 · Norland Corp. · Sep 1991
LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA
K905291 · Lunar · Aug 1991
K922286 · MODEL XCT-900 PQCT X-RAY BONE DENSITOMETER
Download PDF FDA Summary Norland Corp.