PSY
- 产品代码
- PSY
- 器械名称
- Whole Slide Imaging System
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 864.3700
- FDA 专业组
- Pathology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 23 件
FDA 分类定义
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).
该代码近三年的 510(k)（16 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K253554 | 2026-08-07 | Leica Biosystems Imaging, Inc. | Aperio GT 450 DX; Aperio GT 180 DX 摘要 |
| K260964 | 2026-07-22 | Hamamatsu Photonics K.K. | NanoZoomer S540MD Slide Scanner System 摘要 |
| K251952 | 2026-07-17 | Virasoft Corporation | Virasight 摘要 |
| K253606 | 2026-07-15 | Hamamatsu Photonics K.K. | NanoZoomer S20MD Slide scanner system; NanoZoomer S3 摘要 |
| K243871 | 2025-03-06 | Philips Medical Systems Nederland B.V. | Philips IntelliSite Pathology Solution 5.1 摘要 |
| K241717 | 2025-02-28 | Shandon Diagnostics Limited | E1000 Dx Digital Pathology Solution 摘要 |
| K242783 | 2024-12-17 | Ventana Medical Systems, Inc. | Roche Digital Pathology Dx 摘要 |
| K242848 | 2024-12-10 | Philips Medical Systems Nederland B.V. | Philips IntelliSite Pathology Solution 5.1 摘要 |
| K241871 | 2024-12-02 | Philips Medical Systems Nederland B.V. | Philips IntelliSite Pathology Solution 摘要 |
| K233204 | 2024-06-24 | Philips Medical Systems Nederland B.V. | Philips IntelliSite Pathology Solution 5.1 摘要 |
| K232879 | 2024-06-14 | Ventana Medical Systems, Inc. | Roche Digital Pathology Dx (VENTANA DP 200) 摘要 |
| K232833 | 2024-05-07 | Indica Labs, Inc. | HALO AP Dx 摘要 |
| K232208 | 2024-04-16 | Sectra AB | Sectra Digital Pathology Module (Version 3.3) 摘要 |
| K232202 | 2024-04-16 | Leica Biosystems Imaging, Inc. | Aperio GT 450 DX 摘要 |
| K230839 | 2024-02-08 | Proscia, Inc. | Concentriq Dx 摘要 |
| K233027 | 2023-12-22 | Hamamatsu Photonics K.K. | NanoZoomer S360MD Slide scanner system 摘要 |
FDA 官方分类页： PSY
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。