FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Genius Digital Diagnostics System with the Genius Cervical AI algorithm
K Number: DEN210035
·
Decision Jan 31, 2024
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
116
Review Days
887
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Basic Information
- Device Name
- Genius Digital Diagnostics System with the Genius Cervical AI algorithm
- K Number
- DEN210035
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 864.3900
- Medical Specialty
- Pathology
- Decision
- Unknown
- Applicant
- Hologic, Inc.
- Date Received
- August 27, 2021
- Decision Date
- January 31, 2024
- Product Code
- QYV
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QYV | Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm | FDA class 2 | Pathology |
Other Clearances by Hologic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253634 | CoolSeal Generator® (CSL-200-90) | Jun 17, 2026 | Substantially Equivalent |
| K251993 | Panther Fusion GI Expanded Bacterial Assay | Sep 25, 2025 | Substantially Equivalent |
| K243341 | Genius AI Detection 2.0 | Jul 31, 2025 | Substantially Equivalent |
| K243396 | Aptima SARS-CoV-2 Assay | Feb 13, 2025 | Substantially Equivalent |
| K243935 | Aptima CMV Quant Assay | Jan 17, 2025 | Substantially Equivalent |
| K243345 | Aptima BV Assay; Aptima CV/TV Assay | Nov 25, 2024 | Substantially Equivalent |
| K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay | Nov 15, 2024 | Substantially Equivalent |
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) | Jul 25, 2024 | Substantially Equivalent |
| K233352 | Aptima HCV Quant Dx Assay | Jul 24, 2024 | Substantially Equivalent |
| K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Jul 18, 2024 | Substantially Equivalent |