MobileDiagnost wDR 2.2— 510(k) K191813
Substantially EquivalentSedecal., Sa.
FDA 510(k) clearance K191813 for MobileDiagnost wDR 2.2, Substantially Equivalent on 2019-08-02. 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
- Algete, ES
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 K191813
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-0276-2026 — Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system
- Z-2045-2023 — wDR 2.2 Mobile Digital Diagnostic X-Ray System
- Z-1083-2024 — MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191813.
Data sourced from openFDA. This site is unofficial and independent of the FDA.