510(k) K152126 ยท ITX Transducer, Ultrasonic, Diagnostic
UST-5550-R; UST-5536-R; L43K
| Applicant | Hitachi Aloka Medical America, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, Aug 17, 2016 |
| Received | Jul 31, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152126
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2017 | Hitachi Medical Systems America Inc Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures. Terminated |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.