Device product
NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoomer System creates diagnostic-quality digital images of glass slides containing formalin-fixed paraffin-embedded (FFPE) tissue. Catalog Number: C13220-01MD
Z-2280-2023
Product summary
- Event
- Event 92627
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-2280-2023
Official wording
Reason: 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.
Code information: UDI-DI: 010458238901065911220 S/N: 90121100033
Distribution pattern: NY
Derived failure modes
-
Unknown
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.