GADOLINIUM-153 Bone Densitometer (GDC.10413)
FDA 510(k) K901857 · Amersham Corp.
510(k) numberK901857
Submission
- Device name
- GADOLINIUM-153 Bone Densitometer (GDC.10413)
- Applicant
- Amersham Corp.
Arlington Heights, IL, US - Received
- April 24, 1990
- Decision date
- July 9, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K901854 | GADOLINIUM-153 Bone Densitometer (GDC.10411/10412)KGI · Traditional | 07/09/1990SE |
| K901848 | GADOLINIUM-153 Bone Densitometer SourcesKGI · Traditional | 07/09/1990SE |
| K901832 | GADOLINIUM-153 Bone Densitometer Sources GDC.10415KGI · Traditional | 07/09/1990SE |
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Questions and answers
When was GADOLINIUM-153 Bone Densitometer (GDC.10413) cleared by the FDA?
GADOLINIUM-153 Bone Densitometer (GDC.10413) (K901857) received a 510(k) decision of Substantially Equivalent on July 9, 1990, 76 days after the submission was received.
What is the product code of K901857?
The FDA product code is KGI – Densitometer, Bone, a Class II (moderate risk) device regulated under 21 CFR 892.1170.