Devices

Hologic QDR 4500

Model / Serial
S/N: 45264A 45260A 45214A 45241A 45036A 47585C 49124C/CE 47513C 47758C 48342C/NCE 48337C/NCE 49781C/CE 48137C/NCE 47262C 45425SL/CE 45251SL 45751SL/CE 45815SL/CE, and 49521W/CE.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA, Canada, Europe, Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Great Britain, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Macedonia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, Uzbekistan, Algeria, Arab Emirates, Argentina, Australia, Bahrain, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Hong Kong, Indonesia, India, Iran, Iraq, Israel, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Malaysia, Morocco, Mexico, Pakistan, Peru, Puerto Rico, South Africa, Saudia Arabia, Singapore, Syria, Taiwan, Thailand, Tunisia, Venezuela, and Vietnam.
Product Description
Hologic QDR 4500 series Bone Densitometer || Software versions 12.6, 2.3., or 2.4 || Indicated for the estimation of bone mineral density (BMD), comparison of measurable 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.
Manufacturer
Hologic, Inc.
1 Event
- Recall of Hologic QDR 4500

Manufacturer

Hologic, Inc.

Manufacturer Address
Hologic, Inc., 35 Crosby Dr, Bedford MA 01730
Manufacturer Parent Company (2017)
Hologic Inc
Source
USFDA

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