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NORLAND at SWISSRAY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21246482124648NORLAND at SWISSRAY1N2020-04-25W6340 Hackbarth Rd FORT ATKINSON WI US 53538

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00866955000409XR-600 Basic - XR-600 Basic Bone Densitometer920-563-8456pat.cunniff@swissray.com
00866955000416XR-600 Clinical - XR-600 Clinical Bone Desitometer920-563-8456pat.cunniff@swissray.com
00866955000423XR-600 Advanced - 600920-563-8456pat.cunniff@swissray.com
00866955000430XR-800 Basic - XR-800 Basic Bone Densitometer920-563-8456pat.cunniff@swissray.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1668581386188943P990016MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0MUA2000-01-07
1668581432930088K993337APOLLO MULTI-RACIAL REFERENCE POPULATIONKGI2000-05-16
1668581197391865K992125XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46KGI1999-11-22
1668581152259527K980569FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERSKGI1998-06-12
1668581743155202K973459NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERSKGI1998-02-13
1668581955421068K972882APOLLOKGI1997-10-31
1668581665876396K931996MODEL PDEXA BONE DENSITOMETERKGI1995-02-01
1668581320924724K926019FORARM OPT/NORLAND XR SERIES X-RAY BONE DENSITOMETKGI1994-09-23
1668581411565791K913078LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMETKGI1991-09-24
1668581596495612K901804NORLAND XR26 WHOLE BODY OPTIONKGI1991-04-29
1668581179410272K091325TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERSKGI2009-06-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KGI102009-06-29
MUA 12000-01-07

GUDID#