Company ยท US
Hitachi , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2020. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 13, 2020 | K201042 | PROBEAT-CR Hitachi , Ltd., JP | LHN |
| Sep 13, 2019 | K191801 | PROBEAT-CR Hitachi , Ltd., JP | LHN |
| Oct 27, 2017 | K172087 | SANGRAY Hitachi , Ltd., JP | MOT |
| May 30, 2017 | K163505 | ARIETTA PRECISION Hitachi , Ltd. | IYN |
| Dec 15, 2016 | K162902 | ARIETTA Prologue Diagnostic Ultrasound system and Transducers Hitachi , Ltd. | IYN |
| Nov 17, 2016 | K162583 | ALOKA LISENDO 880 Hitachi , Ltd. | IYN |
| Jul 13, 2016 | K161163 | PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory Hitachi , Ltd., JP | LHN |
| Apr 19, 2006 | K060834 | PROBEAT WITH MGCS Hitachi , Ltd. | LHN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||