MX40 Mobile Digital X-ray System
FDA 510(k) K181874 · Huestis Machine Corporation
510(k) numberK181874
Submission
- Device name
- MX40 Mobile Digital X-ray System
- Applicant
- Huestis Machine Corporation
Bristol, RI, US - Received
- July 13, 2018
- Decision date
- September 14, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IZL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260236 | XliteIZL · Traditional | Gemss Healthcare Co., Ltd. | 08/03/2026SE |
| K253058 | Portable DR Imaging SystemIZL · Traditional | Shantou Institute of Ultrasonic Instruments Co.… | 06/18/2026SE |
| K260085 | RAYMO Mobile X-ray System (Model: RAYMO)IZL · Traditional | DRGEM Corporation | 05/14/2026SE |
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemIZL · Traditional | Carestream Health | 03/11/2026SE |
| K253244 | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)IZL · Traditional | Poskom Co., Ltd. | 02/23/2026SE |
| K250976 | Airbile-100IZL · Traditional | Poskom Co., Ltd. | 12/19/2025SE |
| K251710 | Mobile X-ray unit (!M1)IZL · Traditional | Solutions For Tomorrow AB | 10/24/2025SE |
| K243864 | BONX805IZL · Traditional | Bontech Co., Ltd. | 09/12/2025SE |
| K251443 | PromoIZL · Traditional | DRGEM Corporation | 08/22/2025SE |
| K251223 | HnX-P1, HnX-PBIZL · Traditional | H&abyz Co., Ltd. | 08/04/2025SE |
More from H&abyz Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K940145 | Compu-Cutter Therapeutic Shielding Cutting DeviceIYE · Traditional | 01/24/1995SE |
| K926187 | Posicast Immobilization SystemIYE · Traditional | 04/15/1994SE |
| K904005 | Huestis Flexi-BoardJAD · Traditional | 11/29/1990SE |
| K901567 | The Huestis Compu-PlotterIXI · Traditional | 05/31/1990SE |
| K880047 | Huestis Compu-FormerIXI · Traditional | 04/11/1988SE |
| K792721 | Huestis Flexi-HolderIXA · Traditional | 02/19/1980SE |
Questions and answers
When was MX40 Mobile Digital X-ray System cleared by the FDA?
MX40 Mobile Digital X-ray System (K181874) received a 510(k) decision of Substantially Equivalent on September 14, 2018, 63 days after the submission was received.
What is the product code of K181874?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.