FDA.reportPublic FDA data

XR- 800 Clinical

Primary DI
00866955000447
Brand
XR- 800 Clinical
Company
Norland at Swissray
Model
800
Device description
XR- 800 Clinical Bone Densitometer
Published
2017-11-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGIDensitometer, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGIDensitometer, BoneRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992125000XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46Norland Medical Systems, Inc.1999-11-22KGI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866955000447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866955000447008669550004478669550004470866955000447

GMDN Terms#

Term, Definition table
TermDefinition
Bone absorptiometric x-ray system, dual-energyAn assembly of devices designed for bone density measurements and other calculations based on data obtained using a two distinct photon energy peak. Also referred to as a bone densitometer. It utilizes an x-ray tube or tubes as the photon source which are mechanically aligned and moves along with a photon detector assembly typically in a rectilinear pattern. The collimated beam is directed through an anatomical region of interest and the differential absorption patterns are detected. This information is used in calculations to estimate bone mineral density (osteoporosis), subcutaneous fat, fracture risk.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
920-563-8456pat.cunniff@swissray.com

Regulatory Flags#

DUNS number
110329096
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866955000478IlluminatusDXA Software42020-07-27
00866955000409XR-600 Basic 6002017-11-16
00866955000416XR-600 Clinical 6002017-11-16
00866955000423XR-600 Advanced6002017-11-16
00866955000430XR-800 Basic8002017-11-16
00866955000454XR-800 Advanced8002017-11-16
00866955000461EliteElite2017-11-16
00860008461209uREzpocusuREzpocus C-EMS2022-04-25
00860008461216uREzpocusuREzpocus H2022-04-25
00860008461223uREzpocusuREzpocus M2022-04-25
00866955000485uREzpocusuREzpocus C2021-03-15
00866955000492uREzpocusuREzpocus L2021-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
084370217400663D-SHAPER3D-SHAPER MEDICAL S.L.KGI2026-05-12
B214OSTBSIV400TBS iNsightmedimaps group SAKGI2025-02-13
084370217400283D-SHAPER3D-SHAPER MEDICAL S.L.KGI2023-10-04
B052PHCTM40Model 4 CT Calibration PhantomMINDWAYS SOFTWARE, INC.KGI2023-05-04
B214OSPTMV30Phantommedimaps group SAKGI2022-12-08
B214OSPTM3Phantommedimaps group SAKGI2022-12-08
B214OSTBSI3120TBS iNsightmedimaps group SAKGI2022-01-13
00866955000478IlluminatusDXA SoftwareNorland at SwissrayKGI2020-07-27
B214OSTBSI3110TBS iNsightmedimaps group SAKGI2020-06-25
B214OSTBSI3100TBS iNsightmedimaps group SAKGI2020-02-28
B214OSTBSI303TBS iNsightmedimaps group SAKGI2018-08-30
00860000233101VirtuOstO N DIAGNOSTICS LLCKGI2018-08-15
00840682138345ProdigyGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCKGI2018-07-03
00840682138352ProdigyGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCKGI2018-07-03
15420045507494APEX Practice Managment ToolHologic, Inc.KGI2018-04-04
00866955000409XR-600 Basic Norland at SwissrayKGI2017-11-16
00866955000416XR-600 Clinical Norland at SwissrayKGI2017-11-16
00866955000423XR-600 AdvancedNorland at SwissrayKGI2017-11-16
00866955000430XR-800 BasicNorland at SwissrayKGI2017-11-16
00866955000454XR-800 AdvancedNorland at SwissrayKGI2017-11-16
00866955000461EliteNorland at SwissrayKGI2017-11-16
15420045506893Discovery SLHologic, Inc.KGI2017-11-15
15420045506909Discovey CHologic, Inc.KGI2017-11-15
15420045506916Discovery WHologic, Inc.KGI2017-11-15
15420045506879Discovery AHologic, Inc.KGI2017-09-22
04260491560018NAStratec Medizintechnik GmbHKGI2017-04-26
04260491560025NAStratec Medizintechnik GmbHKGI2017-04-26
B052DIASYNC0QCT Pro Asynchronous Calibration Module, CliniQCTMINDWAYS SOFTWARE, INC.KGI2017-03-31
B052DICTXAHIP0CTXA Hip Bone Mineral DensitometerMINDWAYS SOFTWARE, INC.KGI2017-03-31
B052DICTXAHIPEXTDB0CTXA Hip Extended Reference DataMINDWAYS SOFTWARE, INC.KGI2017-03-31