Identity
- Trade Name
- Philips IntelliSite Pathology Solution FDA UDI
- Generic Name
- Microscope slide digital imaging scanner IVD FDA UDI
- Device Name
- Whole Slide Imaging System. The device is an automated digital slide creation, viewing and management system. FDA UDI
- Model / Reference
- 5.1 FDA UDI
- Description
- Whole Slide Imaging System. The device is an automated digital slide creation, viewing and management system. FDA UDI
Identifiers
- Catalog Number
- 760001 FDA UDI
- Primary DI / UDI-DI
- 00884838092105 FDA UDI
- FDA Product Code
- PSY FDA UDI
- GMDN Term
- Microscope slide digital imaging scanner IVD 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
Yes
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: Microscope slide digital imaging scanner IVD
Philips IntelliSite Pathology Solution by Philips Medical Systems Nederland B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Philips Medical Systems Nederland B.V.
Sources (1)
- FDA UDI 795117be-714c-4674-97cb-9025bec17173 35 fields · synced Sep 18, 2026