SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY— 510(k) K101517
Substantially EquivalentSedecal., Sa.
FDA 510(k) clearance K101517 for SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY, Substantially Equivalent on 2011-08-05. 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
- Naples, FL, 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 K101517
K-number listed on FDA's recall record- Z-0242-2026 — Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
- Z-0460-2019 — RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric subjects. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
- Z-2390-2015 — RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.
- Z-1064-2015 — Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101517.
Data sourced from openFDA. This site is unofficial and independent of the FDA.