AcuityPDR Standard
AcuityPDR Standard is a portable basic diagnostic x-ray system (FDA Class II; FDA product code IZL, System, X-Ray, Mobile) made by Radmedix, LLC, cleared under FDA 510(k) K200726 on 13 Apr 2020 and listed in FDA GUDID since 4 May 2020 (UDI-DI 00810035220140), 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 | GUDID listing | Number00810035220140 | Date4 May 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK200726 | Date13 Apr 2020 | StatusActive |
Official records
- AccessGUDID record 00810035220140
- FDA 510(k) database K200726
Across registries
- FDA 510(k) K200726 decided 13 Apr 2020 Active
- FDA GUDID UDI-DI 00810035220140 listed 4 May 2020 Listed
Timeline
- Cleared FDA 510(k) K200726
- Listed FDA GUDID 00810035220140
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AcuityPDR
- Generic name
- Portable basic diagnostic x-ray system, digital
- Model / reference
- Standard
- Primary DI / UDI-DI
- 00810035220140
- 510(k) Number
- FDA product code
- IZL
- GMDN term
- Portable basic diagnostic x-ray system, digital
- Device class
- Class II
- Regulation number
- 892.1720
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Liquid Chemical
Similar devices
Other devices filed under FDA product code IZL (System, X-Ray, Mobile).
- PMX MOBILE X-RAY SYSTEM by Philips Medical Systems
- EPX-Series Mobile X-ray System by Ecotron Co., Ltd
- MobileDiagnost M50 by Philips India Limited
- DRGEM JADE-40 by DRGEM Corporation
- TOPAZ Mobile DR System by DRGEM Corporation
- GENERAL ELECTRIC AMX 110 by Pro-Tronics, Inc.
- UC-5000 Mobile X-Ray by Source-Ray, Inc.
- Diagnostic X-ray System/PLX5200A by Nanjing Perlove Medical Equipment Co., Ltd.
- HnX-P1, HnX-PB by H&abyz Co., Ltd.
- REMEX-T(K)100C by REMEDI Inc.