DeviceClearance

I-View®— 510(k) K254090

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K254090 for I-View®, Substantially Equivalent on 2026-09-02. Applicant: Hologic, Inc.. Device class: 2.

Summary

I-View is from Hologic, Inc., filed under product code MUE (Full Field Digital, System, X-Ray, Mammographic). The record doesn't describe the product beyond its name and code.

Class II, 21 CFR 892.1715. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.

Hologic filed from Newark, Delaware. The decision came 257 calendar days after receipt (December 19, 2025 to September 2, 2026).

Clearance details

Applicant
Hologic, Inc.
Product code
Product code MUE
Device class
Class 2
Regulation
21 CFR 892.1715
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Newark, DE, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MUE

product code MUE
Death
5
Other
1
Total
6

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.