Identity
- Trade Name
- Radmedix AcuityPDR+ FDA UDI
- Generic Name
- Portable basic diagnostic x-ray system, digital FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810035220461 FDA UDI
- 510(k) Number
- K200726 FDA UDI
- FDA Product Code
- IZL FDA UDI
- GMDN Term
- Portable basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Liquid Chemical FDA UDI
Category: Portable basic diagnostic x-ray system, digital
Radmedix AcuityPDR+ by Radmedix, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Portable basic diagnostic x-ray system, digital.
- SIUI — Shantou Institute of Ultrasonic Instruments Co., Ltd. · Class II
- Osstem — Osstem Implant Co., Ltd._Gasan Branch · Class II
- X-ray Flat Panel Detector — CareRay Digital Medical Technology Co., Ltd. · Class II
- Portable X-Ray System — KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. · Class II
- Optima — GE MEDICAL SYSTEMS, INC. · Class II
- Genoray — GENORAY CO., LTD. · Class II
- Genoray — GENORAY CO., LTD. · Class II
- SEDECAL — Sedecal., Sa. · Class II
Cleared under the same submission
K200726 also covers:
- AcuityPDR — Radmedix, LLC
- AcuityPDR — Radmedix, LLC
- AcuityPDR — Radmedix, LLC
- AcuityPDR — Radmedix, LLC
- AcuityPDR — Radmedix, LLC
- AcuityPDR — Radmedix, LLC
- AcuityPDR — Radmedix, LLC
- AcuityPDR — Radmedix, LLC
- AcuityPDR — Radmedix, LLC
- AcuityPDR — Radmedix, LLC
- AcuityPDR — Radmedix, LLC
- AcuityPDR — Radmedix, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Radmedix, LLC
Sources (1)
- FDA UDI b289031c-2026-487c-bc1c-64e590a2401d 33 fields · synced May 30, 2026