Identity
- Trade Name
- FullFocusTM Whole Slide Image Viewer FDA UDI
- Generic Name
- Pathology information system FDA UDI
- Device Name
- FullFocus is a web-based software-only device for viewing and manipulating digital pathology images of glass slides obtained from the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS) on the monitor displays that are validated with verified test methods to meet required performance characteristics. FullFocus renders the uploaded slide images and is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis. FDA UDI
- Model / Reference
- 2.X FDA UDI
- Description
- FullFocus is a web-based software-only device for viewing and manipulating digital pathology images of glass slides obtained from the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS) on the monitor displays that are validated with verified test methods to meet required performance characteristics. FullFocus renders the uploaded slide images and is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860007599101 FDA UDI
- 510(k) Number
- K201005 FDA UDI
- FDA Product Code
- QKQ FDA UDI
- GMDN Term
- Pathology information system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.3700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pathology information system
FullFocusTM Whole Slide Image Viewer by Paige.ai, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Sectra Digital Pathology Module — Sectra AB · Class II
- Sectra Digital Pathology Module — Sectra AB · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Paige.ai, Inc
Sources (1)
- FDA UDI 5dd3343d-32c0-4ca8-abfb-eeda596791d6 34 fields · synced May 30, 2026