Centralite Patient Positioning Laser
Moving Laser Handheld Pendant with holster and cable
5manufacturers in China registered for this device type
23catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Diacor, Inc., United States |
|---|---|
| FDA product code | IWE |
| Device type | Monitor, Patient Position, Light-Beam |
| Device class | Class 1 |
| Regulation | 21 CFR 892.5780 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2023-06-14 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2019-02-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DLL-5R | Withdrawn | |
| MLK-3 | Withdrawn | |
| DLL-4 | Withdrawn | |
| DPS-1 | Withdrawn | |
| DLL-5L | Withdrawn | |
| DLG-4 | Withdrawn | |
| MLC-3 | Withdrawn | |
| MLC-1 | Withdrawn | |
| DLG-6 | Withdrawn | |
| DLL-2 | Withdrawn | |
| MLC-5PC | Withdrawn | |
| MLA-1 | Withdrawn | |
| MLC-1PC | Withdrawn | |
| CTP-1 | Withdrawn | |
| DLG-2 | Withdrawn | |
| MLC-3PC | Withdrawn | |
| MLK-1 | Withdrawn | |
| MLA-1S | Withdrawn | |
| MLK-4 | Withdrawn | |
| MLA-1G | Withdrawn | |
| MLT-2 | Withdrawn | |
| CPM-1 | Withdrawn | |
| MLA-1S-G | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Meicen | Guangdong Meicen Medical Equipment Co., Ltd. | 58 |
| 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 |
| MRI-Safe | Aadco Medical, Inc. | 11 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K954414 | 1995-10-23 |
| K950112 | 1995-08-16 |
| K893398 | 1989-08-17 |
| K872489 | 1987-07-15 |
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.