Intelli-C Accessory
A removable table top for the Intelli-C X-ray system, right side suspended. The removable table enables better space for wheelchair patients inside the C-arc as well as stretcher patients.
5manufacturers in China registered for this device type
13catalogue numbers in this listing
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Nrt – Nordisk Røntgen Teknik A/S |
|---|---|
| FDA product code | OWB |
| Device type | Interventional Fluoroscopic X-Ray System |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| 510(k) | K173631 |
| Record published | 2019-05-01 |
| Record revised | 2023-10-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2022-05-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03285600 | In distribution | |
| 03284000 | In distribution | |
| 21320011 | In distribution | |
| 21320012 | In distribution | |
| 03282200 | In distribution | |
| 21330018 | In distribution | |
| 03282220 | In distribution | |
| 03283500 | In distribution | |
| 21320018 | In distribution | |
| 02919900 | In distribution | |
| 03283000 | Withdrawn | |
| 03282000 | Withdrawn | |
| 03284500 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TrackX | Trackx Technology Inc. | 86 |
| Trinias | Shimadzu Corp. | 54 |
| Allura Xper FD | Philips Medical Systems Nederland B.V. | 21 |
| Azurion | Philips Medical Systems Nederland B.V. | 19 |
| LessRay | Nuvasive, Inc. | 16 |
| Pulse | Nuvasive, Inc. | 12 |
| O-ARM® | Medtronic Navigation, Inc. | 11 |
| Genoray | Genoray Co., Ltd. | 10 |
| Fujifilm Healthcare Americas Corporation | A.T.S. Applicazione Tecnologie Speciali SRL | 7 |
| Fujifilm Medical Systems U.S.A. Inc. | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
| Stephanix | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
| Amrad Medical | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
Showing 12 of 122. All products under Interventional Fluoroscopic X-Ray System
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| NRT X-RAY A/S | 510(k) number | 2024-04-17 | Class II | Device Design | X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and | 35 |
| NRT X-RAY A/S | 510(k) number | 2023-04-27 | Class II | Device Design | There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop. | 32 units |
| NRT X-RAY A/S | 510(k) number | 2023-04-27 | Class II | Device Design | There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop. | 13 units |
| NRT X-RAY A/S | 510(k) number | 2022-01-21 | Class II | Process control | Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down along the patient table while in use with a patient. This accessory is designed to use with Intelli-C, Right and Intelli-C, Left. | 72 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.