QDR-1000 and QDR-1000/W X-Ray Bone Densitometer
FDA 510(k) K905753 · Hologic, Inc.
510(k) numberK905753
Submission
- Device name
- QDR-1000 and QDR-1000/W X-Ray Bone Densitometer
- Applicant
- Hologic, Inc.
Waltham, MA, US - Received
- December 24, 1990
- Decision date
- June 10, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was QDR-1000 and QDR-1000/W X-Ray Bone Densitometer cleared by the FDA?
QDR-1000 and QDR-1000/W X-Ray Bone Densitometer (K905753) received a 510(k) decision of Substantially Equivalent on June 10, 1991, 168 days after the submission was received.
What is the product code of K905753?
The FDA product code is KGI – Densitometer, Bone, a Class II (moderate risk) device regulated under 21 CFR 892.1170.