Identity
- Trade Name
- DMX System FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- The DM-OTC18T is the version of the DMX system which uses an overhead tube crane and performs synchronized tracking but does not perform stitching. This x-ray system can perform a comprehensive range of radiographic procedures. FDA UDI
- Model / Reference
- DM-OTC18T FDA UDI
- Description
- The DM-OTC18T is the version of the DMX system which uses an overhead tube crane and performs synchronized tracking but does not perform stitching. This x-ray system can perform a comprehensive range of radiographic procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858340006165 FDA UDI
- FDA Product Code
- KPR FDA UDI
- GMDN Term
- Stationary basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 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
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
No
FDA UDI
Category: Stationary basic diagnostic x-ray system, digital
DMX System by Del Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Del Medical, Inc.
Sources (1)
- FDA UDI cad2a93a-154c-4279-83c8-650a0352e603 33 fields · synced May 30, 2026