CT Sim+
The CT Sim+, 3-Arm, Green Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation…
The CT Sim+, 3-Arm, Green Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
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 | Sun Nuclear Corporation, United States |
|---|---|
| FDA product code | IWE |
| Device type | Monitor, Patient Position, Light-Beam |
| Device class | Class 1 |
| Regulation | 21 CFR 892.5780 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2023-01-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2017-05-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CT Sim+ | In distribution | |
| CT Sim+ | In distribution | |
| CT Sim+ | In distribution | |
| CT Sim+ | In distribution | |
| CT Sim+ | In distribution | |
| CT Sim+ | In distribution | |
| CT Sim+ | In distribution | |
| CT Sim+ | In distribution | |
| CT Sim+ | In distribution | |
| CT Sim+ | In distribution | |
| CT Sim+ | In distribution | |
| CT Sim+ | In distribution | |
| 805428 | Withdrawn | |
| 805043 | Withdrawn | |
| 804886 | Withdrawn | |
| 805142 | Withdrawn | |
| 805427 | Withdrawn | |
| 805044 | Withdrawn |
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 |
| 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
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.