510(k) K080701 ยท IZL System, X-Ray, Mobile
SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION
| Applicant | Shimadzu Corp., Torrance CA, US |
| Decision | Substantially Equivalent, May 14, 2008 |
| Received | Mar 11, 2008 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K080701
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2020 | Shimadzu Medical Systems Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiogra Open, Classified |
IZL | None listed |
| Jul 19, 2019 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm FDR Go Plus mobile X-ray system Terminated |
IZL | None listed |
| Jan 15, 2019 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm FDR Go PLUS, Mobile X-Ray System
Product Usage:
This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatient Terminated |
IZL | None listed |
| Jan 14, 2019 | Shimadzu Medical Systems Usa Com SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System
Product Usage:
This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot mov Terminated |
IZL | None listed |
| Nov 10, 2015 | Shimadzu Medical Systems Mobile X-ray system MobileDaRt Evolution/FDR Go Software
The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facil Terminated |
IZL | None listed |
| Jun 3, 2013 | Shimadzu Medical Systems Shimadzu Corporation - Mobile DaRt Evolution
This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency Terminated |
IZL | None listed |
| Nov 8, 2012 | Shimadzu Medical Systems 0.4/0.7JG326D-265AX/AT
Product Usage:
The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Terminated |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.