510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K992125Substantially Equivalent

Xr 46 Dxa (Central) Bone Densitometer, Model Xr 46

Norland Medical Systems, Inc., Fort Atkinson WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992125 is the FDA 510(k) clearance record for XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46, a class II device, cleared for Norland Medical Systems, Inc. on under FDA product code KGI (Densitometer, Bone). FDA records list 3 510(k) clearances for Norland Medical Systems, Inc., from to . As of , FDA records show one recall naming K992125.

Clearance record

Decision date
Received
(152 days to decision)
Product code
KGI Densitometer, Bone
Regulation
21 CFR 892.1170
Device class
Class II
Review panel
Radiology
Applicant
Norland Medical Systems, Inc. W-6340 Hackbarth Rd., Fort Atkinson WI
510(k) summary
Summary
Third party review
No

Clearances, product code KGI

Trailing 12 months
2 clearances under product code KGI in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KGI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260