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DMX System

FDA UDI

Class II (US FDA UDI)

by Del Medical, Inc.

Identity

Trade Name
DMX System FDA UDI
Generic Name
Stationary basic diagnostic x-ray system, digital FDA UDI
Device Name
The DM-OTC18S is a version of the DMX x-ray system which allows for stitching and tracking. This system can perform a comprehensive range of radiographic procedures. FDA UDI
Model / Reference
DM-OTC18S FDA UDI
Description
The DM-OTC18S is a version of the DMX x-ray system which allows for stitching and tracking. This system can perform a comprehensive range of radiographic procedures. FDA UDI

Identifiers

Primary DI / UDI-DI
00858340006158 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

Similar devices

Also classified as Stationary basic diagnostic x-ray system, digital.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Del Medical, Inc.

Sources (1)

  • FDA UDI bed999d7-2af1-4286-a404-9dfa8f52c0fd 33 fields · synced Jun 6, 2026