Model note · DEXA Scanner

Norland XR-800 DXA bone densitometer

Name: Norland XR-800 DXA bone densitometer
Brand: Norland

The Norland XR-800 is a central (table) DXA bone densitometer from the Norland line, which passed from Norland Medical Systems to CooperSurgical and is now labelled Norland at Swissray. It runs Norland's Illuminatus DXA software and belongs to the XR family that FDA records tie to the XR 46 clearance, a pencil beam table scanner for hip, spine, forearm and whole body with body composition. Public technical documents for the XR-800 itself are very limited, so this note is short.

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The model

Maker, model and type.

Maker: Norland at Swissray (formerly Norland Medical Systems, then Norland, a CooperSurgical company; Fort Atkinson, Wisconsin)
Model: XR-800 DXA bone densitometer
Device type: DEXA Scanner
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
Variants listed in GUDID	XR-800 Basic, XR-800 Advanced and XR-800 Clinical, model 800, prescription use	Source
Device class and product code	Dual energy bone absorptiometric X-ray system, product code KGI (bone densitometer)	Source
Regulatory basis	FDA recall Z-0213-2012 links the Norland family, including XR-800, to 510(k) K992125	Source
K992125 clearance	XR 46 DXA bone densitometer, cleared 22 November 1999, 21 CFR 892.1170, product code KGI, Class II	Source
Software	Norland Illuminatus DXA software; DICOM option part number 434A133	Source
Scan sites and outputs (XR 46 platform)	Pencil beam table DXA of hip, spine, forearm and whole body; BMD, BMC and area; T-score, Z-score, % young reference and % age matched	Source
Body composition (XR 46 platform)	Lean, fat and % fat, plus hydrostatic weighing equivalents from the Siri and Brozek equations	Source
Software options (2009)	Ten-Year Fracture Risk option (FRAX) and SIRI Table body fat classification option for Norland DXA densitometers	Source

Recalls

Known FDA recalls.

Z-0213-20122011-09-23
Illuminatus DICOM option revisions 4.2.0 to 4.3.1 on XR-600, XR-800, XR-46, Excell, XR-36 and Eclipse could place patient information in a previous patient's record.
FDA record

Safety

Safety warnings from the record.

Patient identity errors in DICOM transfer can attach results to the wrong patient, so confirm demographics before reporting. Source
The fracture risk and SIRI table options give supporting information only; they do not diagnose disease or recommend treatment. Source

Sources

Where this note comes from.

Not covered: Sources are very thin. No Norland or Swissray product page, brochure, operator manual or service manual for the XR-800 could be opened (the Norland website does not respond and trade press and resale listings were blocked), so there are no XR-800 specific X-ray, detector, table, power, dose or precision figures, no QA routine and no error codes. Platform facts come from the 1999 XR 46 510(k), which FDA recall records link to the XR-800 family; confirm with the manufacturer that they apply. The GUDID page itself does not show a premarket number. openFDA MAUDE returned no reports for Norland. The XR-600 was not covered separately. A swap to the DMS Stratos DR was considered, but its public brochure gives almost no numeric specifications either.

BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.

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