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Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
FDA product code QYV · Class 2 · Pathology
9
Registered devices
5
Adverse events
1
Recalls
1
510(k) clearances
Devices with this code
DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-23 | Hologic, Inc | It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufactu |
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