Identity
- Trade Name
- MobileDaRt Evolution FDA UDI
- Generic Name
- Mobile basic diagnostic x-ray system, digital FDA UDI
- Model / Reference
- 503-79999-11 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04540217060832 FDA UDI
- FDA Product Code
- IZL FDA UDI
- GMDN Term
- Mobile 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
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
Category: Mobile basic diagnostic x-ray system, digital
MobileDaRt Evolution by Shimadzu Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mobile basic diagnostic x-ray system, digital.
- Added filter — FUJIFILM Corporation · Class II
- MinXray — Minxray, Inc. · Class II
- SEDECAL — Sedecal., Sa. · Class II
- MinXray — Minxray, Inc. · Class II
- Transportation carriage — FUJIFILM Corporation · Class II
- SEDECAL — Sedecal., Sa. · Class II
- DRX-Revolution Mobile X-ray System — CARESTREAM HEALTH, INC. · Class II
- Mobilett Mira Max — Siemens Healthcare · Class II
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
- Shimadzu Corp.
Sources (1)
- FDA UDI 22ea7a82-2f8e-4bc7-b7d3-5bed1954bf8c 32 fields · synced May 30, 2026