DTX-100

Densitometer, Bone

HOLOGIC, INC.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Dtx-100.

Pre-market Notification Details

• Device ID: K926300
• 510k Number: K926300
• Device Name: DTX-100
• Classification: Densitometer, Bone
• Applicant: HOLOGIC, INC. 590 LINCOLN ST. Waltham, MA 02154
• Contact: Thomas L Kelly
• Correspondent: Thomas L Kelly; HOLOGIC, INC. 590 LINCOLN ST. Waltham, MA 02154
• Product Code: KGI
• CFR Regulation Number: 892.1170 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-12-14
• Decision Date: 1993-07-23