Novo
FDA 510(k) K212361 · PathAI, Inc.
510(k) numberK212361
Submission
- Device name
- Novo
- Applicant
- PathAI, Inc.
Boston, MA, US - Received
- July 30, 2021
- Decision date
- August 11, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QKQ – Digital Pathology Image Viewing And Management Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.3700
- Specialty
- Pathology
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.
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|---|---|---|---|
| K261380 | Concentriq AP-DxQKQ · Traditional | Proscia, Inc. | 08/05/2026SE |
| K243449 | Infinitt DPSQKQ · Traditional | Infinitt Healthcare Co., Ltd. | 12/09/2025SE |
| K252762 | HALO AP DxQKQ · Traditional | Indica Labs, LLC | 11/25/2025SE |
| K243391 | AISight DxQKQ · Traditional | PathAI, Inc. | 06/26/2025SE |
| K250968 | PathPresenter Clinical ViewerQKQ · Traditional | Pathpresenter Corporation | 06/20/2025SE |
| K250414 | CaloPixQKQ · Traditional | Tribun Health | 05/14/2025SE |
| K242244 | Viewer+QKQ · Traditional | Lumea, Inc. | 03/14/2025SE |
| K241273 | FullFocusQKQ · Traditional | Paige.Ai, Inc. | 01/09/2025SE |
| K240303 | MetaLite DX Digital Pathology SoftwareQKQ · Traditional | Jellox Biotech, Inc. | 10/28/2024SE |
| K233126 | aetherSlideQKQ · Traditional | Aetherai Co., Ltd. | 05/30/2024SE |
More from Aetherai Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K243391 | AISight DxQKQ · Traditional | 06/26/2025SE |
Questions and answers
When was Novo cleared by the FDA?
Novo (K212361) received a 510(k) decision of Substantially Equivalent on August 11, 2022, 377 days after the submission was received.
What is the product code of K212361?
The FDA product code is QKQ – Digital Pathology Image Viewing And Management Software, a Class II (moderate risk) device regulated under 21 CFR 864.3700.