MAM-CH22S with Automatic Filter Selection Option
FDA 510(k) K960381 · Elscint, Inc.
510(k) numberK960381
Submission
- Device name
- MAM-CH22S with Automatic Filter Selection Option
- Applicant
- Elscint, Inc.
Hackensack, NJ, US - Received
- January 26, 1996
- Decision date
- April 29, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MAM-CH22S with Automatic Filter Selection Option cleared by the FDA?
MAM-CH22S with Automatic Filter Selection Option (K960381) received a 510(k) decision of Substantially Equivalent on April 29, 1996, 94 days after the submission was received.
What is the product code of K960381?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.