510(k) K243391
- Device
- AISight Dx
- Applicant
- PathAI, Inc.
- 510(k) number
- K243391
- Product code
- QKQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-26
- Date received
- 2024-10-31
- Regulation
- 864.3700
- Classification name
- Digital Pathology Image Viewing And Management Software
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Hisani Madison
- Address
- 1325 Boylston Ave. Suite 10000 Boston MA US 02215 02215
FDA Registration Numbers#
- 3020687180
- 3025774973
- 3031081536
- 3026040791
- 3008491142
- 3039404341
- 3003584784
- 3003989064
- 9615992
- 3039498387
- 3006791373
- 3017125738
Source Documents#
Other 510(k) Records For Product Code QKQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243449 | INFINITT DPS | Infinitt Healthcare Co., Ltd. | 2025-12-09 |
| K252762 | HALO AP Dx | Indica Labs, LLC | 2025-11-25 |
| K250968 | PathPresenter Clinical Viewer | Pathpresenter Corporation | 2025-06-20 |
| K250414 | CaloPix | Tribun Health | 2025-05-14 |
| K242244 | Viewer+ | Lumea, Inc. | 2025-03-14 |
| K241273 | FullFocus | Paige.Ai, Inc. | 2025-01-09 |
| K240303 | MetaLite DX Digital Pathology Software | Jellox Biotech, Inc. | 2024-10-28 |
| K233126 | aetherSlide | Aetherai Co., Ltd. | 2024-05-30 |
| K212361 | Novo | PathAI, Inc. | 2022-08-11 |
| K210811 | Dynamyx Digital Pathology Software | Inspirata, Inc. | 2022-03-01 |
| K201005 | FullFocus | Paige.Ai, Inc. | 2020-07-15 |
| K193054 | Sectra Digital Pathology Module | Sectra AB | 2020-03-31 |