QKQ — Digital Pathology Image Viewing And Management Software Class II
FDA product code QKQ covers "Digital Pathology Image Viewing And Management Software", a Class II medical device regulated under 21 CFR 864.3700. Submissions are reviewed by the Pathology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QKQ
- Device Class
- Class II
- Regulation Number
- 864.3700
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
Definition
Digital pathology image viewing and management software device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243449 | infinitt healthcare co | INFINITT DPS | December 9, 2025 |
| K252762 | indica labs | HALO AP Dx | November 25, 2025 |
| K243391 | pathai | AISight Dx | June 26, 2025 |
| K250968 | pathpresenter corporation | PathPresenter Clinical Viewer | June 20, 2025 |
| K250414 | tribun health | CaloPix | May 14, 2025 |
| K242244 | lumea | Viewer+ | March 14, 2025 |
| K241273 | paige.ai | FullFocus | January 9, 2025 |
| K240303 | jellox biotech | MetaLite DX Digital Pathology Software | October 28, 2024 |
| K233126 | aetherai co | aetherSlide | May 30, 2024 |
| K212361 | pathai | Novo | August 11, 2022 |
| K210811 | inspirata | Dynamyx Digital Pathology Software | March 1, 2022 |
| K201005 | paige.ai | FullFocus | July 15, 2020 |
| K193054 | sectra | Sectra Digital Pathology Module | March 31, 2020 |