Cleared Traditional

TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS

K091325 · Cooper Surgical · Radiology
Jun 2009
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K091325 is an FDA 510(k) clearance for the TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS, a Densitometer, Bone (Class II — Special Controls, product code KGI), submitted by Cooper Surgical (Trumbull, US). The FDA issued a Cleared decision on June 29, 2009, 55 days after receiving the submission on May 5, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1170.

Submission Details

510(k) Number K091325 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2009
Decision Date June 29, 2009
Days to Decision 55 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KGI — Densitometer, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1170

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