# K213883: NanoZoomer S360MD Slide scanner system

- Pathway: 510(k) (Traditional)
- Applicant: Hamamatsu Photonics K.K.
- Decided: Sep 27, 2022 after 288 days
- Product code: PSY (Whole Slide Imaging System)
- Device class: 2
- Regulation: 21 CFR 864.3700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN160056 (2017). 1 ancestor in all.
14 later devices descend from it; 6 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160056: Philips IntelliSite Pathology Solution, Philips Medical Systems Nederland B.V. (2017) Summary page 4.

## Most influential descendants
- K233027: NanoZoomer S360MD Slide scanner system (2023), 7 descendants of its own
- K230839: Concentriq Dx (2024), 1 descendant of its own
- K261380: Concentriq AP-Dx (2026), 0 descendants of its own
- K260964: NanoZoomer S540MD Slide Scanner System (2026), 0 descendants of its own
- K251952: Virasight (2026), 0 descendants of its own

## Recalls of this device
- Jun 6, 2023 · Class II · Z-2280-2023: If the wrong barcode information is recorded in the NDPi file, a pathologist may refer to the whole slide image (WSI) of a different patient.

## Indications for use
NanoZoomer S360MD Slide scanner system (“NanoZoomer System™) is an automated digital slide creation, viewing, and management system. The NanoZoomer System is intended for in vitro diagnostic use 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 NanoZoomer System is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. The NanoZoomer System comprises the NanoZoomer S360MD Slide scanner, the NZViewMD Software and the JVC Kenwood JD-C240BNO1A display. The NanoZoomer System is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using NanoZoomer System.

Source page: https://510kreport.com/device/K213883
Methodology: https://510kreport.com/methodology