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OrthoScan HD Mini C-arm

FDA UDI

Class II (US FDA UDI)

by Ziehm-Orthoscan, Inc.

Identity

Trade Name
OrthoScan HD Mini C-arm FDA UDI
Generic Name
Portable general-purpose fluoroscopic x-ray system, digital FDA UDI
Device Name
Image-intensified fluoroscopic x-ray system, mobile FDA UDI
Model / Reference
1000-0004 FDA UDI
Description
Image-intensified fluoroscopic x-ray system, mobile FDA UDI

Identifiers

Primary DI / UDI-DI
B225100000040 FDA UDI
510(k) Number
K051754 FDA UDI
FDA Product Code
OXO FDA UDI
JAA FDA UDI
GMDN Term
Portable general-purpose fluoroscopic x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 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: Portable general-purpose fluoroscopic x-ray system, digital

OrthoScan HD Mini C-arm by Ziehm-Orthoscan, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Portable general-purpose fluoroscopic x-ray system, digital.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ziehm-Orthoscan, Inc.

Sources (1)

  • FDA UDI 5c96a1d0-d4c0-4e89-aa01-b6b84ed67bd9 36 fields · synced May 30, 2026