The following data is part of a premarket notification filed by Hitachi Ltd. with the FDA for Probeat-cr.
| Device ID | K191801 |
| 510k Number | K191801 |
| Device Name: | PROBEAT-CR |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | Hitachi Ltd. 3-1-1, Saiwai-cho Hitachi-shi, JP 317-8511 |
| Contact | Tomoyuki Seino |
| Correspondent | Jonathan Kahan Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-03 |
| Decision Date | 2019-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560333350006 | K191801 | 000 |