TOPAZ Mobile DR System
by DRGEM Corporation 2 variants
510(k) K201124
TOPAZ Mobile DR System is a medical device (FDA Class II; FDA product code IZL, System, X-Ray, Mobile) made by DRGEM Corporation, cleared under FDA 510(k) K201124 on 19 May 2020, 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 | NumberK201124 | Date19 May 2020 | StatusActive |
Official records
- FDA 510(k) database K201124
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- Withdrawn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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