Option for the QDR Bone Densitometer, Models QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W

Q: What is the product code of K992775?

The FDA product code is KGI – Densitometer, Bone, a Class II (moderate risk) device regulated under 21 CFR 892.1170.

FDA 510(k) K992775 · Hologic, Inc.

Substantially Equivalent

510(k) numberK992775

Submission

Device name: Option for the QDR Bone Densitometer, Models QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
Applicant: Hologic, Inc.
Bedford, MA, US
Received: August 18, 1999
Decision date: October 1, 1999
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KGI – Densitometer, Bone
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1170
Specialty: Radiology

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K220822	3D-SHAPERKGI · Traditional	3D-Shaper Medical S.L	12/09/2022SE
K213760	ABMD SoftwareKGI · Traditional	HeartLung Corporation	07/29/2022SE
K191112	GEHC DXA Bone Densitometers with enCORE version 18KGI · Traditional	GE Medical Systems Ultrasound & Primary Care…	09/19/2019SE
K180782	AriaKGI · Traditional	GE Medical Systems Ultrasound & Primary Care…	04/20/2018SE

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Questions and answers

When was Option for the QDR Bone Densitometer, Models QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W cleared by the FDA?

Option for the QDR Bone Densitometer, Models QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W (K992775) received a 510(k) decision of Substantially Equivalent on October 1, 1999, 44 days after the submission was received.

What is the product code of K992775?

The FDA product code is KGI – Densitometer, Bone, a Class II (moderate risk) device regulated under 21 CFR 892.1170.