Mammorx
FDA 510(k) K930246 · Diacor, Inc.
510(k) numberK930246
Submission
- Device name
- Mammorx
- Applicant
- Diacor, Inc.
Salt Lake City, UT, US - Received
- January 19, 1993
- Decision date
- July 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Mammorx cleared by the FDA?
Mammorx (K930246) received a 510(k) decision of Substantially Equivalent on July 26, 1993, 188 days after the submission was received.
What is the product code of K930246?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.