I-View®
FDA 510(k) K254090 · Hologic, Inc.
510(k) numberK254090
Submission
- Device name
- I-View®
- Applicant
- Hologic, Inc.
Newark, DE, US - Received
- December 19, 2025
- Decision date
- September 2, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was I-View® cleared by the FDA?
I-View® (K254090) received a 510(k) decision of Substantially Equivalent on September 2, 2026, 257 days after the submission was received.
What is the product code of K254090?
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.