DRX-Revolution Mobile X-ray System
FDA 510(k) K191025 · Carestream Health, Inc.
510(k) numberK191025
Submission
- Device name
- DRX-Revolution Mobile X-ray System
- Applicant
- Carestream Health, Inc.
Rochester, NY, US - Received
- April 18, 2019
- Decision date
- May 17, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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More from H&abyz Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemIZL · Traditional | 03/11/2026SE |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…KPR · Traditional | 01/20/2026SE |
| K251168 | Image SuiteLLZ · Traditional | 09/04/2025SE |
| K241505 | DRX-Revolution Mobile X-ray SystemIZL · Traditional | 12/10/2024SE |
| K233381 | DRX-Evolution Plus SystemKPR · Traditional | 03/12/2024SE |
| K223842 | DRX - CompassKPR · Special | 01/20/2023SE |
| K213568 | DRX-Rise Mobile X-ray SystemIZL · Traditional | 03/23/2022SE |
| K213307 | Eclipse II with Smart Noise CancellationMQB · Traditional | 01/14/2022SE |
| K202441 | Eclipse II with Smart Noise CancellationMQB · Traditional | 04/02/2021SE |
| K203159 | Lux 35 DetectorMQB · Special | 12/02/2020SE |
Questions and answers
When was DRX-Revolution Mobile X-ray System cleared by the FDA?
DRX-Revolution Mobile X-ray System (K191025) received a 510(k) decision of Substantially Equivalent on May 17, 2019, 29 days after the submission was received.
What is the product code of K191025?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.