Norland At Swissray

FDA Filings

This page includes the latest FDA filings for Norland At Swissray. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 2124648
• FEI Number: 2124648
• Name: NORLAND at SWISSRAY
• Owner & Operator: Swissray International, Inc.
• Contact Address: 1090 King Georges Post Road Unit 1203; Edison NJ 08837 US
• Official Correspondent:
  • Deniz K Kortan
  • 01-908-3726408-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: W6340 Hackbarth Rd ; FORT ATKINSON, WI 53538 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00860008461223 Norland at Swissray	uREzpocus	2022-05-03
GUDID 00860008461216 Norland at Swissray	uREzpocus	2022-05-03
GUDID 00860008461209 Norland at Swissray	uREzpocus	2022-05-03
GUDID 00866955000492 Norland at Swissray	uREzpocus	2021-03-23
GUDID 00866955000485 Norland at Swissray	uREzpocus	2021-03-23
GUDID 00866955000478 Norland at Swissray	IlluminatusDXA Software	2020-08-04
GUDID 00866955000461 Norland at Swissray	Elite	2018-07-06
GUDID 00866955000454 Norland at Swissray	XR-800 Advanced	2018-07-06
GUDID 00866955000447 Norland at Swissray	XR- 800 Clinical	2018-07-06
GUDID 00866955000430 Norland at Swissray	XR-800 Basic	2018-07-06
GUDID 00866955000423 Norland at Swissray	XR-600 Advanced	2018-07-06
GUDID 00866955000416 Norland at Swissray	XR-600 Clinical	2018-07-06
GUDID 00866955000409 Norland at Swissray	XR-600 Basic	2018-07-06
PMN P990016 | MUA NORLAND at SWISSRAY [Swissray International, Inc.]	Norland, McCue CUBA Clinical Ultrasonic Bone Sonometry System	2014-01-16
PMN K993337 | KGI NORLAND at SWISSRAY [Swissray International, Inc.]	Norland, Apollo Multi Radical Reference Population	2014-01-16
PMN K992125 | KGI NORLAND at SWISSRAY [Swissray International, Inc.]	XR 800 DXA Bone Densitometer	2014-01-16
PMN K992125 | KGI NORLAND at SWISSRAY [Swissray International, Inc.]	XR 600 DXA Bone Densitometer	2014-01-16
PMN K992125 | KGI NORLAND at SWISSRAY [Swissray International, Inc.]	XR 46 DXA Bone Densitometer	2014-01-16
PMN K992125 | KGI NORLAND at SWISSRAY [Swissray International, Inc.]	ELITE DXA Bone Densitometer	2014-01-16
PMN K980569 | KGI NORLAND at SWISSRAY [Swissray International, Inc.]	Norland, Fracture Risk Analysis	2014-01-16
PMN K973459 | KGI NORLAND at SWISSRAY [Swissray International, Inc.]	Norland, Body Composition Option	2014-01-16
PMN K972882 | KGI NORLAND at SWISSRAY [Swissray International, Inc.]	Norland Apollo Bone Densitometer	2014-01-16
PMN K931996 | KGI NORLAND at SWISSRAY [Swissray International, Inc.]	pDEXA Bone Densitometer	2014-01-16
PMN K926019 | KGI NORLAND at SWISSRAY [Swissray International, Inc.]	Norland, Forearm Scan Option	2014-01-16
PMN K913078 | KGI NORLAND at SWISSRAY [Swissray International, Inc.]	Norland, Lateral Spine Option	2014-01-16
PMN K901804 | KGI NORLAND at SWISSRAY [Swissray International, Inc.]	Norland, Whole Body Scan Option	2014-01-16
PMN K091325 | KGI NORLAND at SWISSRAY [Swissray International, Inc.]	Ten Year Fracture Risk	2014-01-16
PMN K091325 | KGI NORLAND at SWISSRAY [Swissray International, Inc.]	SIRI Table Option for Norland DXA Bone Densitometer	2014-01-16

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018092766116	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	MACHINERY PARTS HTN 90221400	2 PKG
2018092573137	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	MACHINERY PARTS HTN 90221400	2 PKG