Identity
- Trade Name
- DX-D 100 FDA UDI
- Generic Name
- Mobile basic diagnostic x-ray system, digital FDA UDI
- Device Name
- DX-D 100 MOB WLS DR 50KW (300KHU)/110V FDA UDI
- Model / Reference
- 5411/050 FDA UDI
- Description
- DX-D 100 MOB WLS DR 50KW (300KHU)/110V FDA UDI
Identifiers
- Catalog Number
- 5R78W FDA UDI
- Primary DI / UDI-DI
- 05414904094440 FDA UDI
- 510(k) Number
- K103597 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
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
Category: Mobile basic diagnostic x-ray system, digital
Dx-D 100 by Agfa 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.
- MobileDaRt Evolution — Shimadzu Corp. · Class II
- 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
Cleared under the same submission
K103597 also covers:
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
- Agfa Corp.
Sources (1)
- FDA UDI eb1b9794-0f25-497e-b894-b343ce3ab2e8 36 fields · synced May 30, 2026