PSY · Whole Slide Imaging System · Chrysalis Intelligence

Device class

Class II

Regulation 864.3700

Total clearances

2021-04-15 → 2026-08-07

Last 12 months

Unique sponsors

Definition

What is Whole Slide Imaging System

The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. The system generates digital images that would otherwise be appropriate for manual visualization by conventional brightfield microscopy. The whole slide imaging system is not intended for use with slides prepared from frozen tissue, cytology, and non-FFPE hematopathology specimens (e.g., peripheral blood smear).

Classification details

Medical specialty

Pathology

Review panel

Regulation number

864.3700

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Philips Medical Systems Nederland B.V.	5	0	2025-03-06
Hamamatsu Photonics K.K.	4	2	2026-07-22
Leica Biosystems Imaging, Inc.	2	1	2026-08-07
Ventana Medical Systems, Inc.	2	0	2024-12-17
Barco N.V.	1	0	2021-04-15
Indica Labs, Inc.	1	0	2024-05-07
Sectra AB	1	0	2024-04-16
Shandon Diagnostics Limited	1	0	2025-02-28
Proscia, Inc.	1	0	2024-02-08
Virasoft Corporation	1	1	2026-07-17

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
88373	CPT	—	High	Whole slide imaging system processing and digital pathology interpretation
88305	CPT	—	Medium	Level IV histopathology exam for surgical pathology slide review

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-07	K253554	Leica Biosystems Imaging, Inc.	Aperio GT 450 DX; Aperio GT 180 DX
2026-07-22	K260964	Hamamatsu Photonics K.K.	NanoZoomer S540MD Slide Scanner System
2026-07-17	K251952	Virasoft Corporation	Virasight
2026-07-15	K253606	Hamamatsu Photonics K.K.	NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system
2025-03-06	K243871	Philips Medical Systems Nederland B.V.	Philips IntelliSite Pathology Solution 5.1
2025-02-28	K241717	Shandon Diagnostics Limited	E1000 Dx Digital Pathology Solution
2024-12-17	K242783	Ventana Medical Systems, Inc.	Roche Digital Pathology Dx
2024-12-10	K242848	Philips Medical Systems Nederland B.V.	Philips IntelliSite Pathology Solution 5.1
2024-12-02	K241871	Philips Medical Systems Nederland B.V.	Philips IntelliSite Pathology Solution
2024-06-24	K233204	Philips Medical Systems Nederland B.V.	Philips IntelliSite Pathology Solution 5.1
2024-06-14	K232879	Ventana Medical Systems, Inc.	Roche Digital Pathology Dx (VENTANA DP 200)
2024-05-07	K232833	Indica Labs, Inc.	HALO AP Dx
2024-04-16	K232208	Sectra AB	Sectra Digital Pathology Module (Version 3.3)
2024-04-16	K232202	Leica Biosystems Imaging, Inc.	Aperio GT 450 DX
2024-02-08	K230839	Proscia, Inc.	Concentriq Dx
2023-12-22	K233027	Hamamatsu Photonics K.K.	NanoZoomer S360MD Slide scanner system
2022-09-27	K213883	Hamamatsu Photonics K.K.	NanoZoomer S360MD Slide scanner system
2021-09-17	K203845	Philips Medical Systems Nederland B.V.	Philips IntelliSite Pathology Solution
2021-04-15	K203364	Barco N.V.	MDPC-8127