510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931996Substantially Equivalent

Model Pdexa Bone Densitometer

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

K931996 is the FDA 510(k) clearance record for MODEL PDEXA BONE DENSITOMETER, a class II device, cleared for Norland Corp. on under FDA product code KGI (Densitometer, Bone). FDA records list 15 510(k) clearances for Norland Corp., from to . As of , FDA records show no recalls naming K931996.

Clearance record

Decision date
Received
(649 days to decision)
Product code
KGI Densitometer, Bone
Regulation
21 CFR 892.1170
Device class
Class II
Review panel
Radiology
Applicant
Norland Corp. W6340 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