K200282 is an FDA 510(k) clearance for the Orfit Aerial Couchtop. This device is classified as a System, Radiation Therapy, Charged-particle, Medical (Class II - Special Controls, product code LHN).
Submitted by Orfit Industries NV (Wijnegem, BE). The FDA issued a Cleared decision on April 8, 2020, 64 days after receiving the submission on February 4, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K200282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2020 |
| Decision Date | April 08, 2020 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | LHN - System, Radiation Therapy, Charged-particle, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |