Identity
- Trade Name
- Bi Image X-Evolution Wall FDA UDI
- Generic Name
- Stationary extraoral dental x-ray system, digital FDA UDI
- Device Name
- An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts. FDA UDI
- Model / Reference
- EL-X20070 FDA UDI
- Description
- An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts. FDA UDI
Identifiers
- Catalog Number
- PC17B FDA UDI
- Primary DI / UDI-DI
- 10850786008014 FDA UDI
- 510(k) Number
- K160458 FDA UDI
- FDA Product Code
- EHD FDA UDI
- GMDN Term
- Stationary extraoral dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1800 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stationary extraoral dental x-ray system, digital
Bi Image X-Evolution Wall by Dpm Usa Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Dpm Usa Corp.
Sources (1)
- FDA UDI 21aa1e36-5c1e-408e-af60-1c29f0317206 35 fields · synced May 30, 2026