MRI-Safe
Single LCD Mount W/ ARM AND Dual Column Internal Wiring MRI Safe
5manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (2), Guangdong (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Guangdong Meicen Medical Equipment Co., Ltd. | Foshan | Guangdong | Manufacturer | 7 |
| Shenzhen Tengfei YU Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Aadco Medical, Inc., United States |
|---|---|
| FDA product code | IWE |
| Device type | Monitor, Patient Position, Light-Beam |
| Device class | Class 1 |
| Regulation | 21 CFR 892.5780 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OSL-100NF | In distribution | |
| OSL-100WNF | In distribution | |
| OSL-200NF | In distribution | |
| OSPL-200NF | In distribution | |
| OSPL-200WNF | In distribution | |
| OSPL-202HNF | In distribution | |
| OSPL-201NF | In distribution | |
| OSL-101NF | In distribution | |
| OSL-101WNF | In distribution | |
| OSL-201NF | In distribution | |
| OSPL-100NF | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Meicen | Guangdong Meicen Medical Equipment Co., Ltd. | 58 |
| Centralite Patient Positioning Laser | Diacor, Inc. | 23 |
| Dorado | L A P Gmbh Laser Applikationen | 20 |
| Hercules | Aadco Medical, Inc. | 18 |
| CT Sim+ | Sun Nuclear Corporation | 18 |
| Aadco | Aadco Medical, Inc. | 14 |
| HIT Laser | C-RAD Positioning AB | 13 |
| Sun Nuclear Micro+ | Sun Nuclear Corporation | 12 |
| Carina | L A P Gmbh Laser Applikationen | 10 |
| Apollo | L A P Gmbh Laser Applikationen | 10 |
| Sun Nuclear Micro+ MR | Sun Nuclear Corporation | 6 |
| Huestis Centralite Patient Positioning Laser | Huestis Machine Corp. | 6 |
Showing 12 of 26. All products under Monitor, Patient Position, Light-Beam
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.