K191801 is an FDA 510(k) clearance for the PROBEAT-CR. This device is classified as a System, Radiation Therapy, Charged-particle, Medical (Class II - Special Controls, product code LHN).
Submitted by Hitachi , Ltd. (Hitachi-Shi, JP). The FDA issued a Cleared decision on September 13, 2019, 72 days after receiving the submission on July 3, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K191801 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2019 |
| Decision Date | September 13, 2019 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LHN - System, Radiation Therapy, Charged-particle, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |