FullFocus
FDA 510(k) K241273 · Paige.Ai, Inc.
510(k) numberK241273
Submission
- Device name
- FullFocus
- Applicant
- Paige.Ai, Inc.
New York, NY, US - Received
- May 6, 2024
- Decision date
- January 9, 2025
- 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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| K243449 | Infinitt DPSQKQ · Traditional | Infinitt Healthcare Co., Ltd. | 12/09/2025SE |
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| 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 |
| K240303 | MetaLite DX Digital Pathology SoftwareQKQ · Traditional | Jellox Biotech, Inc. | 10/28/2024SE |
| K233126 | aetherSlideQKQ · Traditional | Aetherai Co., Ltd. | 05/30/2024SE |
| K212361 | NovoQKQ · Traditional | PathAI, Inc. | 08/11/2022SE |
More from PathAI, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K201005 | FullFocusQKQ · Traditional | 07/15/2020SE |
Questions and answers
When was FullFocus cleared by the FDA?
FullFocus (K241273) received a 510(k) decision of Substantially Equivalent on January 9, 2025, 248 days after the submission was received.
What is the product code of K241273?
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.