Genius Digital Diagnostics System with the Genius Cervical AI algorithm
Summary
Hologic, Inc. received 510(k) clearance for Genius Digital Diagnostics System with the Genius Cervical AI algorithm, a QYV device. Cleared on 2024-01-31.
Details
Source
510(k) Clearance
External ID
DEN210035
Action Date
2024-01-31
Status
Direct
Category
device
Product Code
QYV
Product Description
Genius Digital Diagnostics System with the Genius Cervical AI algorithm. Product code: QYV.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Hologic, Inc. has received 19 total clearances in our database.
Hologic, Inc. has 41 FDA actions in our database, including 22 recalls and 19 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Hologic, Inc. have FDA actions?
Hologic, Inc. has 41 FDA actions in our database, including 22 recalls and 19 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "DEN210035" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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