The following data is part of a premarket notification filed by Orfit Industries Nv with the FDA for Orfit Aerial Couchtop.
| Device ID | K200282 |
| 510k Number | K200282 |
| Device Name: | Orfit Aerial Couchtop |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | Orfit Industries NV 9A, Vosveld Wijnegem, BE 2110 |
| Contact | Eddy Marivoet |
| Correspondent | Ray Kelly Arazy Group Consultants Inc. 3422 Leonardo Ln New Smyrna Beach, FL 32168 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-04 |
| Decision Date | 2020-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05420028716649 | K200282 | 000 |
| 05420028716632 | K200282 | 000 |