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ScanX Ortho

FDA UDI

Class II (US FDA UDI)

by Air Techniques, Inc.

Identity

Trade Name
ScanX Ortho FDA UDI
Generic Name
Radiography digital imaging scanner FDA UDI
Device Name
Scan X Ortho Digital Imaging System FDA UDI
Model / Reference
F3750 FDA UDI
Description
Scan X Ortho Digital Imaging System FDA UDI

Identifiers

Primary DI / UDI-DI
D678F37500 FDA UDI
510(k) Number
K013893 FDA UDI
FDA Product Code
MUH FDA UDI
GMDN Term
Radiography digital imaging scanner 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Dimensions & Sizes

Size
Height — 24.5 Inch FDA UDI
Depth — 15.5 Inch FDA UDI
Width — 15.5 Inch FDA UDI

Category: Radiography digital imaging scanner

ScanX Ortho by Air Techniques, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiography digital imaging scanner.

Cleared under the same submission

K013893 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Air Techniques, Inc.

Sources (1)

  • FDA UDI df1ab1e6-b9cf-49c7-a643-33c99d111411 36 fields · synced Jun 9, 2026