QKQ — Digital Pathology Image Viewing And Management Software Class II
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 |