MX40 Mobile Digital X-ray System
by Huestis Machine Corporation
510(k) K181874
MX40 Mobile Digital X-ray System is a medical device (FDA Class II; FDA product code IZL, System, X-Ray, Mobile) made by Huestis Machine Corporation, cleared under FDA 510(k) K181874 on 14 Sep 2018, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK181874 | Date14 Sep 2018 | StatusActive |
Official records
- FDA 510(k) database K181874
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IZL
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1720
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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