JADE Mobile X-Ray
510(k) K183388
JADE Mobile X-Ray is a medical device (FDA Class II; FDA product code IZL, System, X-Ray, Mobile) made by DRGEM Corporation, cleared under FDA 510(k) K183388 on 5 Feb 2019, 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 | NumberK183388 | Date5 Feb 2019 | StatusActive |
Official records
- FDA 510(k) database K183388
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- Withdrawn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
Devices cleared under K183388
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| DRGEM JADE-32 | JADE-32 | 08800011150082 | — | On the market |
| DRGEM JADE-40 | JADE-40 | 08800011150099 | — | On the market |
Similar devices
Other devices filed under FDA product code IZL (System, X-Ray, Mobile).
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- GM85 by Samsung Electronics Co.,Ltd
- SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110 by Soyee Product, Inc.