XR- 800 Clinical

FDA UDI

Class II (US FDA UDI)

by Norland at Swissray

Identity

Trade Name: XR- 800 Clinical FDA UDI
Generic Name: Bone absorptiometric x-ray system, dual-energy FDA UDI
Device Name: XR- 800 Clinical Bone Densitometer FDA UDI
Model / Reference: 800 FDA UDI
Description: XR- 800 Clinical Bone Densitometer FDA UDI

Identifiers

Primary DI / UDI-DI: 00866955000447 FDA UDI
510(k) Number: K992125 FDA UDI
FDA Product Code: KGI FDA UDI
GMDN Term: Bone absorptiometric x-ray system, dual-energy FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1170 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

Category: Bone absorptiometric x-ray system, dual-energy

XR- 800 Clinical by Norland at Swissray — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K992125 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: Norland at Swissray

Sources (1)

FDA UDI b8f458d8-cf33-47c9-b798-15531797c14e 35 fields · synced Jun 6, 2026