The following data is part of a premarket notification filed by Ehmetdx, Llc with the FDA for X-ray Imaging System For The Mclaren Proton Treatment System.
| Device ID | K181498 |
| 510k Number | K181498 |
| Device Name: | X-ray Imaging System For The McLaren Proton Treatment System |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | EhmetDx, LLC 47801 W Anchor Ct Plymouth, MI 48170 |
| Contact | Daniel Schoettlin |
| Correspondent | Daniel Schoettlin EhmetDx, LLC 47801 W Anchor Ct Plymouth, MI 48170 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-07 |
| Decision Date | 2018-12-10 |
| Summary: | summary |