Identity
- Trade Name
- Mikroscan FDA UDI
- Generic Name
- Microscope slide digital imaging scanner IVD FDA UDI
- Device Name
- The dual mode SL5-E system from Mikroscan offers the user two completely separate and distinctly different capabilities in one convenient device. The user selects either the live microscope mode using a fully functional, remotely controlled robotic microscope or a static digital pathology scanner for the creation of whole-slide images. The protection features of the equipment may be impaired if the device is used in a manner not specified by Mikroscan. FDA UDI
- Model / Reference
- SL5-E FDA UDI
- Description
- The dual mode SL5-E system from Mikroscan offers the user two completely separate and distinctly different capabilities in one convenient device. The user selects either the live microscope mode using a fully functional, remotely controlled robotic microscope or a static digital pathology scanner for the creation of whole-slide images. The protection features of the equipment may be impaired if the device is used in a manner not specified by Mikroscan. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860002275628 FDA UDI
- FDA Product Code
- IBJ FDA UDI
- GMDN Term
- Microscope slide digital imaging scanner IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3600 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
Yes
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
Mikroscan by Mikroscan Technologies Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microscope slide digital imaging scanner IVD.
- Tissue-Tek® SmartWrite® — Sakura Finetek USA, Inc · Class I
- Philips IntelliSite Pathology Solution — Philips Medical Systems Nederland B.V. · Class II
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc. · Class II
- VisionTek® M6 — Sakura Finetek USA, Inc · Class I
- Philips IntelliSite Pathology Solution — Philips Medical Systems Nederland B.V. · Class II
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc. · Class II
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc. · Class II
- NanoZoomer S360MD Slide scanner system — Hamamatsu Photonics K.K. · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Mikroscan Technologies Inc
Sources (1)
- FDA UDI cc6bc652-66cb-47e3-ad97-fa950c007036 34 fields · synced May 30, 2026