The following data is part of a premarket notification filed by Gammex, Inc. with the FDA for Ct Sim Laser System.
| Device ID | K152303 |
| 510k Number | K152303 |
| Device Name: | CT Sim Laser System |
| Classification | Monitor, Patient Position, Light-beam |
| Applicant | GAMMEX, INC. 7600 DISCOVERY DRIVE Middleton, WI 53562 |
| Contact | Kenneth Windisch |
| Correspondent | James Luker SUN NUCLEAR CORPORATION 3275 Suntree Blvd. Melbourne, FL 32940 |
| Product Code | IWE |
| CFR Regulation Number | 892.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-14 |
| Decision Date | 2015-09-11 |
| Summary: | summary |