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Singapore HSA registration DE0007311

Hologic Discovery QDR® X-Ray Bone Densitometers

Singapore flagSingapore·CLASS C·Hologic, Inc·Registered July 29, 2011
Device classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0007311
Registration Date
July 29, 2011
Change Notification Approval Date
January 16, 2017
Retention Due Date
July 28, 2025
Product description
The QDR X-Ray Bone Densitometers are indicated for use in the estimation of bone mineral content (BMC) and/or bone mineral density (BMD) performed at various anatomical sites, including periprosthetic bone. The APEX for QDR X-Ray Bone Densitometers is indicated for the estimation of bone mineral density (BMD), comparison of measured variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics using the Hologic QDR X-Ray Bone Densitometers.
Product Owner
Name
Hologic, Inc
Short Name
Hologic
Address
35 Crosby Drive, Bedford,, MA, UNITED STATES
Registrant
Name
MEDICAL IMAGING SYSTEMS PTE. LTD.
Address
28 SIN MING LANE, MIDVIEW CITY, #02-143, SINGAPORE 573972
Importer
Name
MEDICAL IMAGING SYSTEMS PTE. LTD.
Address
3006 UBI ROAD 1, KAMPONG UBI INDUSTRIAL ESTATE, #02-336, SINGAPORE 408700
Model information
Model Name(s)
Discovery A Discovery C Discovery Ci Discovery SL Discovery W Discovery Wi APEX Software
Model Identifier(s)
Discovery-A Discovery-C Discovery-Ci Discovery-SL Discovery-W Discovery-Wi QDR CD
About this record

Access comprehensive regulatory information for Hologic Discovery QDR® X-Ray Bone Densitometers in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0007311 and owned by Hologic, Inc. The device was registered on July 29, 2011.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C