Identity
- Trade Name
- DIGITAL DIAGNOSTICS SYSTEM FDA UDI
- Generic Name
- Microscope slide digital imaging scanner IVD FDA UDI
- Device Name
- 72TB server for use with the Genius™ Digital Diagnostics System for short term digital storage. FDA UDI
- Model / Reference
- INFORMATION MANAGEMENT SYSTEM, LARGE FDA UDI
- Description
- 72TB server for use with the Genius™ Digital Diagnostics System for short term digital storage. FDA UDI
Identifiers
- Catalog Number
- ASY-14451 FDA UDI
- Primary DI / UDI-DI
- 15420045513976 FDA UDI
- 510(k) Number
- DEN210035 FDA UDI
- FDA Product Code
- QYV FDA UDI
- GMDN Term
- Microscope slide digital imaging scanner IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.3900 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: Laboratory instrument/analyser application software IVDMicroscope slide digital imaging scanner IVD
Digital Diagnostics System by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Microscope slide digital imaging scanner IVD.
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- Philips IntelliSite Pathology Solution — Philips Medical Systems Nederland B.V. · Class II
- NanoZoomer S360MD Slide scanner system — Hamamatsu Photonics K.K. · Class II
- EUROArrayScanner — EUROIMMUN Medizinische Labordiagnostika AG · Class II
- Aperio GT 450 DX (US) Scanner — Leica Biosystems Imaging, Inc. · Class II
- Mikroscan — MIKROSCAN TECHNOLOGIES INC · Class I
Cleared under the same submission
DEN210035 also covers:
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.
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
- Hologic, Inc.
Sources (1)
- FDA UDI c1223095-a036-4705-a431-a34afe2aa8c5 37 fields · synced Jun 1, 2026