Identity
- Trade Name
- Table, 3-D Imaging C-Arm, 115 VAC EUDAMED3D Imaging C-Arm Table, 115V FDA UDI
- Generic Name
- Fluoroscopy/angiography table, powered FDA UDI
- Device Name
- Surgical C-Arm Tables EUDAMEDThe 3D Imaging C-Arm Table 820 is designed and equipped for use with 3D imaging rings and 3D C-Arms for general C-Arm and O-Arm applications. The table features motorized actuation of height, X-Y, lateral roll and Trendelenburg motions of the tabletop. FDA UDI
- Model / Reference
- 058-820 EUDAMEDFDA UDI
- Description
- The 3D Imaging C-Arm Table 820 is designed and equipped for use with 3D imaging rings and 3D C-Arms for general C-Arm and O-Arm applications. The table features motorized actuation of height, X-Y, lateral roll and Trendelenburg motions of the tabletop. FDA UDI
Identifiers
- Catalog Number
- 058-820 FDA UDI
- Primary DI / UDI-DI
- 00879942070514 EUDAMEDFDA UDI
- Basic UDI-DI
- 085994200610756 EUDAMED
- Direct Marketing DI
- 00879942070514 EUDAMED
- FDA Product Code
- FQO FDA UDI
- EMDN Code
- Z12011202 OPERATING TABLES EUDAMED
- GMDN Term
- Fluoroscopy/angiography table, powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Table, 3-D Imaging C-Arm, 115 VAC by Mirion Technologies (Capintec), Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 085994200610756 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mirion Technologies (Capintec), Inc.
- EUDAMED SRN
- US-MF-000000770
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (2)
- EUDAMED 919b31c0-0a69-41b6-8b70-35ee77a4053d 61 fields · synced Jun 19, 2026
- FDA UDI adbc4ec2-9693-42ec-8995-93a41be55fc4 35 fields · synced May 29, 2026