Tilting Mag
FDA 510(k) K921896 · Continental X-Ray Corp.
510(k) numberK921896
Submission
- Device name
- Tilting Mag
- Applicant
- Continental X-Ray Corp.
Broadview, IL, US - Received
- April 22, 1992
- Decision date
- August 3, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Tilting Mag cleared by the FDA?
Tilting Mag (K921896) received a 510(k) decision of Substantially Equivalent on August 3, 1992, 103 days after the submission was received.
What is the product code of K921896?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.