HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY

Densitometer, Bone

HOLOGIC, INC.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Hologic Qdr X-ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery.

Pre-market Notification Details

• Device ID: K023398
• 510k Number: K023398
• Device Name: HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
• Classification: Densitometer, Bone
• Applicant: HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730
• Contact: Richard L Follett
• Correspondent: Richard L Follett; HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730
• Product Code: KGI
• CFR Regulation Number: 892.1170 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-10-09
• Decision Date: 2002-11-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15420045506916	K023398	000
15420045505698	K023398	000
15420045505827	K023398	000
15420045505834	K023398	000
15420045505865	K023398	000
15420045505872	K023398	000
15420045505889	K023398	000
15420045506879	K023398	000
15420045506893	K023398	000
15420045506909	K023398	000
15420045505384	K023398	000