Contrast Enhanced Digital Mammography
FDA 510(k) K123873 · Hologic, Inc.
510(k) numberK123873
Submission
- Device name
- Contrast Enhanced Digital Mammography
- Applicant
- Hologic, Inc.
Bedford, MA, US - Received
- December 17, 2012
- Decision date
- January 29, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Contrast Enhanced Digital Mammography cleared by the FDA?
Contrast Enhanced Digital Mammography (K123873) received a 510(k) decision of Substantially Equivalent on January 29, 2013, 43 days after the submission was received.
What is the product code of K123873?
The FDA product code is MUE – Full Field Digital, System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1715.