Eu Ivdr
Eu Ivd Class A
On The Market
๐บ๐ธ United States
FullFocus
Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 00860007599101
- Basic UDI-DI Code
- 08600075991FFIVPE
- Reference
- FullFocus
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Paige.AI, Inc.
Additional Description
FullFocus is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret, and manage digital images of pathology slides for primary diagnosis. FullFocus is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0202050382 | LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - SOFTWARE ACCESSORIES |
Available In Countries
๐ฌ๐ง United Kingdom
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