Identity
- Trade Name
- VisionTek® M6 FDA UDI
- Generic Name
- Microscope slide digital imaging scanner IVD FDA UDI
- Device Name
- Digital Microscope FDA UDI
- Model / Reference
- 9006 FDA UDI
- Description
- Digital Microscope FDA UDI
Identifiers
- Catalog Number
- 9006 FDA UDI
- Primary DI / UDI-DI
- 00615233082312 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
Yes
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
Yes
FDA UDI
Category: Microscope slide digital imaging scanner IVD
VisionTek® M6 by Sakura Finetek USA, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microscope slide digital imaging scanner IVD.
- Philips IntelliSite Pathology Solution — Philips Medical Systems Nederland B.V. · Class II
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc. · Class II
- 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
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc. · Class II
- EUROArrayScanner — EUROIMMUN Medizinische Labordiagnostika AG · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sakura Finetek USA, Inc
Sources (1)
- FDA UDI a5e5ea43-7fb7-4b32-bc6f-be604c4a369c 35 fields · synced Jun 8, 2026