ScanX Quantum (without battery)

FDA UDI

Class II (US FDA UDI)

by Air Techniques, Inc.

Identity

Trade Name: ScanX Quantum (without battery) FDA UDI
Generic Name: Radiography digital imaging scanner FDA UDI
Device Name: The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display. FDA UDI
Model / Reference: D5000Q FDA UDI
Description: The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display. FDA UDI

Identifiers

Primary DI / UDI-DI: D678D5000Q0 FDA UDI
510(k) Number: K101289 FDA UDI
FDA Product Code: MQB FDA UDI
GMDN Term: Radiography digital imaging scanner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1680 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 — 43 Pound FDA UDI
Height — 14 Inch FDA UDI
Length — 18 Inch FDA UDI
Width — 15.5 Inch FDA UDI

Category: Radiography digital imaging scanner

ScanX Quantum (without battery) by Air Techniques, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K101289 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 6af26870-afad-48aa-be4f-d65397d94737 37 fields · synced Jun 9, 2026