FDA product code QYV: Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
QYV is the FDA product code for digital cervical cytology slide imaging system with artificial intelligence algorithm. It is a Class II device, regulated under 21 CFR 864.3900 and reviewed by the Pathology panel. Devices under QYV reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it. FDA has posted 1 recall for QYV devices, 1 initiated in the last five years.
Definition
The digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm is a prescription in vitro diagnostic device consisting of an automated digital slide creation, viewing, and management system intended to aid in the review of digital images of slides prepared from Pap test specimens and conventional Pap smears by selecting and presenting areas of interest to facilitate interpretation by the reader. The AI software algorithm uses machine learning techniques to provide information to the user about the presence, location, or characteristics of areas of the image with clinical implications. Information from this device is intended to assist the user in rendering a cytology diagnosis.
Classification
| Field | Value |
|---|---|
| Device name | Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm |
| Device class | Class II |
| Regulation | 21 CFR 864.3900 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) |
Recalls for QYV devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-03-23.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code QYV?
QYV is the FDA product code for digital cervical cytology slide imaging system with artificial intelligence algorithm. It is a Class II device, regulated under 21 CFR 864.3900 and reviewed by the Pathology panel.
What device class is QYV?
Class II, regulation 21 CFR 864.3900. Typical premarket route: 510(k).
Have QYV devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2026-03-23.
Next steps
- Run an FDA pathway report with predicate devices for product code QYV
- Run a recall and safety report across every QYV manufacturer
- Watch product code QYV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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