510(k) clearance
I-View®
- 510(k) number
- K254090
- Applicant
- Hologic, Inc.
- Decision date
- Sep 2, 2026
- Date received
- Dec 19, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MUE
- Device type
- Full Field Digital, System, X-Ray, Mammographic
- Device class
- Class II
- Regulation
- 21 CFR 892.1715
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Newark, DE, US