AcuityDRe
510(k) K210919
AcuityDRe is a medical device (FDA Class II; FDA product code MQB, Solid State X-Ray Imager (Flat Panel/Digital Imager)) made by Radmedix, LLC, cleared under FDA 510(k) K210919 on 30 Apr 2021, 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 | NumberK210919 | Date30 Apr 2021 | StatusActive |
Official records
- FDA 510(k) database K210919
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQB
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K210919
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 | |||
|---|---|---|---|---|
| AcuityDRe 1 | 1 | 00810035220447 | — | On the market |
| Radmedix AcuityDRe 1417w | 1 | 00810035220478 | — | On the market |
| Radmedix AcuityDRe 1717t | 1 | 00810035220546 | — | On the market |
| Radmedix AcuityDRe 1717w | 1 | 00810035220485 | — | On the market |
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