Identity
- Trade Name
- Intelli-C Left Side Suspended Table FDA UDI
- Generic Name
- Stationary angiographic x-ray system, digital FDA UDI
- Device Name
- The Intelli-C X-ray device is a multi-purpose - also sometimes known as a universal C-arm fluoroscopy system, designed for diagnostic medical imaging examinations, from barium studies to interventional and angiography studies. FDA UDI
- Model / Reference
- 03400010 FDA UDI
- Description
- The Intelli-C X-ray device is a multi-purpose - also sometimes known as a universal C-arm fluoroscopy system, designed for diagnostic medical imaging examinations, from barium studies to interventional and angiography studies. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713464000121 FDA UDI
- 510(k) Number
- K173631 FDA UDI
- FDA Product Code
- JAA FDA UDIOWB FDA UDI
- GMDN Term
- Stationary angiographic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stationary angiographic x-ray system, digital
Intelli-C Left Side Suspended Table by Nrt - Nordisk Røntgen Teknik A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stationary angiographic x-ray system, digital.
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- Allura Xper FD — Philips Medical Systems Nederland B.V. · Class II
- Trinias — Shimadzu Corp. · Class II
- Allura Xper FD — Philips Medical Systems Nederland B.V. · Class II
- Trinias — Shimadzu Corp. · Class II
- Artis Q biplane — Siemens Healthcare · Class II
Cleared under the same submission
K173631 also covers:
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
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
- Nrt - Nordisk Røntgen Teknik A/S
Sources (1)
- FDA UDI 04a7aa9b-5cff-4784-aab6-aa3b4d6e3007 35 fields · synced Jun 6, 2026