Identity
- Trade Name
- Anatomage Table FDA UDI
- Generic Name
- Radiology information system application software FDA UDI
- Device Name
- Anatomage Table is a volumetric imaging software designed specifically for clinicians, doctors, physicians, and other qualified medical professionals. The software runs in Windows operating systems and visualizes medical imaging data on the computer screen. Users are to able examine anatomy on a computer screen and use software tools to move and manipulate rendered images by turning, zooming, flipping, adjusting contrast and brightness, cutting, and slicing using either a touch interface or standard mouse and keyboard interactions. FDA UDI
- Model / Reference
- 5.0.1 FDA UDI
- Description
- Anatomage Table is a volumetric imaging software designed specifically for clinicians, doctors, physicians, and other qualified medical professionals. The software runs in Windows operating systems and visualizes medical imaging data on the computer screen. Users are to able examine anatomy on a computer screen and use software tools to move and manipulate rendered images by turning, zooming, flipping, adjusting contrast and brightness, cutting, and slicing using either a touch interface or standard mouse and keyboard interactions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852060007013 FDA UDI
- 510(k) Number
- K140093 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology information system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology information system application software
Anatomage Table by Anatomage, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Anatomage, Inc.
Sources (2)
- FDA UDI 1318f4dd-3a3b-47c6-bd55-91fcedfbe130 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026