Digital Pathology Image Viewing And Management Software
Digital Pathology Image Viewing And Management Software is a Class 2 pathology software device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue, serving as an aid to pathologists for reviewing and interpreting digital images for the purposes of primary diagnosis. It requires 510(k) clearance and is regulated under 21 CFR 864.3700 within the Pathology medical specialty. The product code is QKQ. The device is not an implant and is not flagged as life-sustaining.
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Basic Information
- Product Code
- QKQ
- Device Class
- FDA class 2
- Regulation Number
- 864.3700
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243449 | INFINITT DPS | Dec 09, 2025 | Substantially Equivalent | Infinitt Healthcare Co., Ltd. |
| K252762 | HALO AP Dx | Nov 25, 2025 | Substantially Equivalent | Indica Labs, LLC |
| K243391 | AISight Dx | Jun 26, 2025 | Substantially Equivalent | PathAI, Inc. |
| K250968 | PathPresenter Clinical Viewer | Jun 20, 2025 | Substantially Equivalent | Pathpresenter Corporation |
| K250414 | CaloPix | May 14, 2025 | Substantially Equivalent | Tribun Health |
| K242244 | Viewer+ | Mar 14, 2025 | Substantially Equivalent | Lumea, Inc. |
| K241273 | FullFocus | Jan 09, 2025 | Substantially Equivalent | Paige.Ai, Inc. |
| K240303 | MetaLite DX Digital Pathology Software | Oct 28, 2024 | Substantially Equivalent | Jellox Biotech, Inc. |
| K233126 | aetherSlide | May 30, 2024 | Substantially Equivalent | Aetherai Co., Ltd. |
| K212361 | Novo | Aug 11, 2022 | Substantially Equivalent | PathAI, Inc. |
| K210811 | Dynamyx Digital Pathology Software | Mar 01, 2022 | Substantially Equivalent | Inspirata, Inc. |
| K201005 | FullFocus | Jul 15, 2020 | Substantially Equivalent | Paige.Ai, Inc. |
| K193054 | Sectra Digital Pathology Module | Mar 31, 2020 | Substantially Equivalent | Sectra AB |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.