ScanX Intraoral for Centralized Imaging

FDA UDI

Class II (US FDA UDI)

by Air Techniques, Inc.

Identity

Trade Name: ScanX Intraoral for Centralized Imaging FDA UDI
Generic Name: Radiography digital imaging scanner FDA UDI
Device Name: ScanX Intraoral for Centralized Imaging 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: F3605 FDA UDI
Description: ScanX Intraoral for Centralized Imaging 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

Catalog Number: F3600 FDA UDI
Primary DI / UDI-DI: D678F36050 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 — 16 Inch FDA UDI
Depth — 15.5 Inch FDA UDI
Width — 15.5 Inch FDA UDI
Weight — 44 Pound FDA UDI

Category: Radiography digital imaging scanner

ScanX Intraoral for Centralized Imaging 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.

Vidar Systems Corporation — Vidar Systems Corp. · Class II
Vidar Systems Corporation — Vidar Systems Corp. · Class II
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Air Techniques, Inc.

Sources (1)

FDA UDI 3ea1feab-457c-4014-9bd3-f92e0ca367ef 38 fields · synced Jun 9, 2026