ScanX Duo

FDA UDI

Class II (US FDA UDI)

by Air Techniques, Inc.

Identity

Trade Name: ScanX Duo FDA UDI
Generic Name: Radiography digital imaging scanner FDA UDI
Device Name: The ScanX Scanner is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose. FDA UDI
Model / Reference: D1100 FDA UDI
Description: The ScanX Scanner is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose. FDA UDI

Identifiers

Primary DI / UDI-DI: D678D11000 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Height — 12 Inch FDA UDI
Depth — 10.375 Inch FDA UDI
Width — 10 Inch FDA UDI
Weight — 21.5 Pound FDA UDI

Category: Radiography digital imaging scanner

ScanX Duo 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.

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ScanX Swift View — DÜRR DENTAL SE · Class II
FireCR — DIGIRAY Corp. · Class II
Vidar Systems Corporation — Vidar Systems Corp. · Class II
ScanX Intraoral View — Durr Dental AG · Class II
Vidar Systems Corporation — Vidar Systems Corp. · Class II
Vidar Systems Corporation — Vidar Systems Corp. · Class II

Cleared under the same submission

K013893 also covers:

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: Air Techniques, Inc.

Sources (1)

FDA UDI d64bc2fe-7888-462c-ad07-3ccf5667cf53 37 fields · synced Jun 9, 2026