The following data is part of a premarket notification filed by Hitachi Ltd. Healthcare Hitachi Works with the FDA for Mini Ridge Filter And Auxiliary Functions For Probeat-v.
| Device ID | K181676 |
| 510k Number | K181676 |
| Device Name: | Mini Ridge Filter And Auxiliary Functions For PROBEAT-V |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | Hitachi Ltd. Healthcare Hitachi Works 3-1-1, Saiwai-Cho Hitachi, JP 317-8511 |
| Contact | Tomoyuki Seino |
| Correspondent | Jonathan Kahan Hogan Lovells US LLP 555 13th Street NW Washington, DC 20016 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-25 |
| Decision Date | 2018-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560333350211 | K181676 | 000 |