510(k) K213883
- Device
- NanoZoomer S360MD Slide Scanner System
- Applicant
- Hamamatsu Photonics K.K.
- 510(k) number
- K213883
- Product code
- PSY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-09-27
- Date received
- 2021-12-13
- Regulation
- 864.3700
- Classification name
- Whole Slide Imaging System
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Shinichi Fujisaka
- Address
- 812, Joko-Cho, Higashi-Ku Hamamatsu City JP 431-3196 431-3196
FDA Registration Numbers#
- 3017125738
- 9614683
- 3006791373
- 9613188
- 3000126629
- 3012563754
- 3003584784
- 3005060446
- 1000181154
- 2028492
- 3025774973
- 3008491142
Source Documents#
Other 510(k) Records For Product Code PSY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243871 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | 2025-03-06 |
| K241717 | E1000 Dx Digital Pathology Solution | Shandon Diagnostics Limited | 2025-02-28 |
| K242783 | Roche Digital Pathology Dx | Ventana Medical Systems, Inc. | 2024-12-17 |
| K242848 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | 2024-12-10 |
| K241871 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2024-12-02 |
| K233204 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | 2024-06-24 |
| K232879 | Roche Digital Pathology Dx (VENTANA DP 200) | Ventana Medical Systems, Inc. | 2024-06-14 |
| K232833 | HALO AP Dx | Indica Labs, Inc. | 2024-05-07 |
| K232208 | Sectra Digital Pathology Module (Version 3.3) | Sectra AB | 2024-04-16 |
| K232202 | Aperio GT 450 DX | Leica Biosystems Imaging, Inc. | 2024-04-16 |
| K230839 | Concentriq Dx | Proscia, Inc. | 2024-02-08 |
| K233027 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2023-12-22 |
| K203845 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2021-09-17 |
| K203364 | MDPC-8127 | Barco N.V. | 2021-04-15 |
| K192259 | Philips IntelliSite Pathology Solution | Philips Electronics Nederland B.V. | 2019-09-20 |
Legacy Summary#
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FDA Review#
Decision Summary