MAM-2 Microfocus Mammography System W/Magnifi.
FDA 510(k) K884676 · Elscint, Inc.
510(k) numberK884676
Submission
- Device name
- MAM-2 Microfocus Mammography System W/Magnifi.
- Applicant
- Elscint, Inc.
Itasca, IL, US - Received
- November 8, 1988
- Decision date
- January 6, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was MAM-2 Microfocus Mammography System W/Magnifi. cleared by the FDA?
MAM-2 Microfocus Mammography System W/Magnifi. (K884676) received a 510(k) decision of Substantially Equivalent on January 6, 1989, 59 days after the submission was received.
What is the product code of K884676?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.