DRX-Revolution Mobile X-ray System— 510(k) K191025
Substantially EquivalentCarestream Health, Inc.
FDA 510(k) clearance K191025 for DRX-Revolution Mobile X-ray System, Substantially Equivalent on 2019-05-17. Applicant: Carestream Health, Inc.. Device class: 2.
Clearance details
- Applicant
- Carestream Health, 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
- Rochester, NY, US
Recent devices under product code IZL
view allMore clearances from Carestream Health, 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 K191025
K-number listed on FDA's recall record- Z-0289-2024 — The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of standard stationary x-ray room. The DRX-Revolution system incorporates a flat-panel detector that can be used wirelessly for exams such as in-bed chest projections. The system can also be used to expose CR phosphor screens or films.
- Z-0437-2024 — DRX Revolution Mobile X-Ray System
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191025.
Data sourced from openFDA. This site is unofficial and independent of the FDA.