SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION— 510(k) K080701
Substantially EquivalentShimadzu Corp.
FDA 510(k) clearance K080701 for SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION, Substantially Equivalent on 2008-05-14. Applicant: Shimadzu Corp.. Device class: 2.
Clearance details
- Applicant
- Shimadzu Corp.
- Product code
- Code IZL
- Device class
- Class 2
- Regulation
- 21 CFR 892.1720
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Torrance, CA, US
Recent devices under product code IZL
view allMore clearances from Shimadzu Corp.
view allAdverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K080701
K-number listed on FDA's recall record- Z-0534-2021 — 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 radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
- Z-2441-2019 — Fujifilm FDR Go Plus mobile X-ray system
- Z-1040-2019 — 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 outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)>
- Z-1039-2019 — 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 move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR).
- Z-0451-2016 — 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 facility who cannot move and outpatients in emergency.
- Z-1369-2013 — 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 .
- Z-0265-2013 — 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080701.
Data sourced from openFDA. This site is unofficial and independent of the FDA.