ScanX Swift Digital Imaging System

FDA UDI

Class II (US FDA UDI)

by Air Techniques, Inc.

Identity

Trade Name: ScanX Swift Digital Imaging System FDA UDI
Generic Name: Radiography digital imaging scanner FDA UDI
Device Name: 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. This kit contains an installation disc, USB cable and power supply, PSPs, barrier envelopes, barrier film rolls, PSP wipes, and a scanner cleaning sheet. FDA UDI
Model / Reference: G8010 FDA UDI
Description: 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. This kit contains an installation disc, USB cable and power supply, PSPs, barrier envelopes, barrier film rolls, PSP wipes, and a scanner cleaning sheet. FDA UDI

Identifiers

Primary DI / UDI-DI: D678G80100 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: Weight — 14.5 Pound FDA UDI
Outer Diameter — 9.6 Inch FDA UDI
Height — 9.2 Inch FDA UDI
Width — 8.9 Inch FDA UDI

Category: Radiography digital imaging scanner

ScanX Swift Digital Imaging System 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 7d5ff76f-f9db-45c2-9270-810f42142eba 37 fields · synced Jun 9, 2026