MOBILEDIAGNOST WDR— 510(k) K111725
Substantially EquivalentSedecal., Sa.
FDA 510(k) clearance K111725 for MOBILEDIAGNOST WDR, Substantially Equivalent on 2011-07-19. Applicant: Sedecal., Sa.. Device class: 2.
Clearance details
- Applicant
- Sedecal., Sa.
- 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
- Special
- Location
- Seneca, SC, US
Recent devices under product code IZL
view allMore clearances from Sedecal., Sa.
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 K111725
K-number listed on FDA's recall record- Z-0243-2026 — MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
- Z-1083-2024 — MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
- Z-1084-2016 — Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
- Z-1691-2016 — Sedecal SA Mobile Diagnost w DR x-ray system
- Z-1040-2015 — MobileDiagnost wDR motorized portable diagnostic X-ray systems.
- Z-0508-2015 — Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with the patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
- Z-1964-2013 — Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing, or lying in the prone or supine positions. Not intended for mammography.
- Z-1706-2017 — Mobile Diagnostic X-Ray System with Digital Panel
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111725.
Data sourced from openFDA. This site is unofficial and independent of the FDA.