MOBILETT MIRA— 510(k) K111912
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K111912 for MOBILETT MIRA, Substantially Equivalent on 2011-09-19. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- 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
- Mavern, PA, US
Recent devices under product code IZL
view allMore clearances from Siemens Medical Solutions USA, Inc.
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 K111912
K-number listed on FDA's recall record- Z-0223-2024 — Mobilett Mira wireless (VA20) mobile x-ray system(s)
- Z-1875-2013 — Mobiletta Mira Mobile X-ray System
- Z-0480-2013 — Siemens Mobilette Mira, intended use as Mobile x-ray system.
- Z-2322-2012 — Siemens Mobilett Mira. Mobile X-Ray System.
- Z-2367-2012 — Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111912.
Data sourced from openFDA. This site is unofficial and independent of the FDA.