Device class
Class II
Regulation 864.3700
Total clearances
15
2020-03-31 → 2026-08-07
Definition
What is Digital Pathology Image Viewing And Management Software
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.
Classification details
Medical specialty
Pathology
Regulation number
864.3700
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Paige.Ai, Inc.
|
2 |
0 |
2025-01-09 |
|
PathAI, Inc. |
2 |
0 |
2025-06-26 |
|
Pathpresenter Corporation |
1 |
0 |
2025-06-20 |
|
Aetherai Co., Ltd. |
1 |
0 |
2024-05-30 |
|
Jellox Biotech, Inc. |
1 |
0 |
2024-10-28 |
|
Indica Labs, LLC |
1 |
1 |
2025-11-25 |
|
Lumea, Inc. |
1 |
0 |
2025-03-14 |
|
Tribun Health |
1 |
0 |
2025-05-14 |
|
Leica Biosystems Imaging, Inc.
|
1 |
1 |
2026-08-07 |
|
Infinitt Healthcare Co., Ltd.
|
1 |
1 |
2025-12-09 |
|
Sectra AB |
1 |
0 |
2020-03-31 |
|
Proscia, Inc. |
1 |
1 |
2026-08-05 |
|
Inspirata, Inc. |
1 |
0 |
2022-03-01 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 88399 |
CPT
|
— |
Low
|
Unlisted surgical pathology code; digital pathology software billing is evolving |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-08-07 |
K253561 |
Leica Biosystems Imaging, Inc.
|
Aperio iQC DX Software |
| 2026-08-05 |
K261380 |
Proscia, Inc.
|
Concentriq AP-Dx |
| 2025-12-09 |
K243449 |
Infinitt Healthcare Co., Ltd.
|
INFINITT DPS |
| 2025-11-25 |
K252762 |
Indica Labs, LLC
|
HALO AP Dx |
| 2025-06-26 |
K243391 |
PathAI, Inc.
|
AISight Dx |
| 2025-06-20 |
K250968 |
Pathpresenter Corporation
|
PathPresenter Clinical Viewer |
| 2025-05-14 |
K250414 |
Tribun Health
|
CaloPix |
| 2025-03-14 |
K242244 |
Lumea, Inc.
|
Viewer+ |
| 2025-01-09 |
K241273 |
Paige.Ai, Inc.
|
FullFocus |
| 2024-10-28 |
K240303 |
Jellox Biotech, Inc.
|
MetaLite DX Digital Pathology Software |
| 2024-05-30 |
K233126 |
Aetherai Co., Ltd.
|
aetherSlide |
| 2022-08-11 |
K212361 |
PathAI, Inc.
|
Novo |
| 2022-03-01 |
K210811 |
Inspirata, Inc.
|
Dynamyx Digital Pathology Software |
| 2020-07-15 |
K201005 |
Paige.Ai, Inc.
|
FullFocus |
| 2020-03-31 |
K193054 |
Sectra AB
|
Sectra Digital Pathology Module |