Neusoft Medical Systems Co L T D

FDA Filings

This page includes the latest FDA filings for Neusoft Medical Systems Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003575350
• FEI Number: 3003575350
• Name: Wang Jun(Mario Wang)
• Owner & Operator: NEUSOFT MEDICAL SYSTEMS CO., LTD.
• Contact Address: No.177-1 Chuangxin Road Hunnan District; Shenyang CN-21 Liaoning 110167 CN
• US Agent:
  • Wang Jun(Mario Wang)
  • NEUSOFT MEDICAL SYSTEM U.S.A. INC
  • 281 4531205
  • 281 4531201
  • mario.wang@us.neusoft.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 14425 Torrey Chase Blvd,Suite 100 ; HOUSTON, TX 77014 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3008364908
• FEI Number: 3008364908
• Name: NEUSOFT MEDICAL SYSTEMS U.S.A.,Inc.
• Owner & Operator: NEUSOFT MEDICAL SYSTEMS CO., LTD.
• Contact Address: No.177-1 Chuangxin Road Hunnan District; Shenyang CN-21 Liaoning 110167 CN
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 2711 Centerville Rd,Suite400 ; Wilmington, DE 19808 US

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
GUDID 06970167441616 Neusoft Medical Systems Co., Ltd.	NeuViz 128 Multi-Slice CT Scanner System	2023-10-31
GUDID 06970167440046 Neusoft Medical Systems Co., Ltd.	NeuViz 128 Multi-slice CT Scanner System	2018-10-29
GUDID 06970167440053 Neusoft Medical Systems Co., Ltd.	NeuSight PET/CT Scanner System	2018-06-15
GUDID 06970167440084 Neusoft Medical Systems Co., Ltd.	NeuViz 16 Essence Multi-Slice CT Scanner System	2018-04-16
GUDID 06970167440077 Neusoft Medical Systems Co., Ltd.	NeuViz Prime Multi-Slice CT Scanner System	2018-04-16
GUDID 06970167440060 Neusoft Medical Systems Co., Ltd.	NeuSight PET/CT Scanner System	2018-03-29
GUDID 06970167440039 Neusoft Medical Systems Co., Ltd.	NeuViz 64 Multi-slice CT Scanner System	2018-03-29
GUDID 06970167440022 Neusoft Medical Systems Co., Ltd.	NeuViz 64 Multi-slice CT Scanner System	2018-03-29
GUDID 06970167440015 Neusoft Medical Systems Co., Ltd.	NeuViz 64 Multi-slice CT Scanner System	2018-03-29
GUDID 06970167440008 Neusoft Medical Systems Co., Ltd.	NeuViz 64 Multi-slice CT Scanner System	2018-03-29
PMN K171201 | LLZ Wang Jun(Mario Wang) [NEUSOFT MEDICAL SYSTEMS CO., LTD.]	NeuViz Prime Multi-Slice CT Scanner System	2018-03-12
PMN K171201 | JAK Wang Jun(Mario Wang) [NEUSOFT MEDICAL SYSTEMS CO., LTD.]	NeuViz Prime Multi-Slice CT Scanner System	2018-03-12
PMN K171198 | JAK Wang Jun(Mario Wang) [NEUSOFT MEDICAL SYSTEMS CO., LTD.]	NeuViz 16 Essence Multi-Slice CT Scanner System	2018-03-12
PMN K080548 | IYO Wang Jun(Mario Wang) [NEUSOFT MEDICAL SYSTEMS CO., LTD.]	HD6, HD7	2017-12-21
PMN K080548 | IYN Wang Jun(Mario Wang) [NEUSOFT MEDICAL SYSTEMS CO., LTD.]	HD6, HD7	2017-12-21
PMN K080548 | ITX Wang Jun(Mario Wang) [NEUSOFT MEDICAL SYSTEMS CO., LTD.]	HD6, HD7	2017-12-21
PMN K171198 Neusoft Medical Systems Co., Ltd.	NeuViz 16 Essence Multi-slice CT Scanner System	2017-12-07
PMN K171201 Neusoft Medical Systems Co., Ltd.	NeuViz Prime Multi-slice CT Scanner System	2017-09-13
PMN K151383 | JAK Wang Jun(Mario Wang) [NEUSOFT MEDICAL SYSTEMS CO., LTD.]	NeuViz 128	2015-11-05
PMN K151383 NEUSOFT MEDICAL SYSTEMS CO., LTD.	NeuViz 128 Multi-slice CT Scanner System	2015-11-04
PMN K151403 NEUSOFT MEDICAL SYSTEMS CO., LTD.	Positron Emission Tomography (PET) And Computed Tomography (CT) System, Positron Emission Tomography (PET) And Computed Tomography (CT) System	2015-11-02
PMN K133373 NEUSOFT MEDICAL SYSTEMS CO., LTD.	CLEARVIEW	2014-12-03
PMN K133373 | JAK Wang Jun(Mario Wang) [NEUSOFT MEDICAL SYSTEMS CO., LTD.]	ClearView	2014-12-03
PMN K121792 | JAK Wang Jun(Mario Wang) [NEUSOFT MEDICAL SYSTEMS CO., LTD.]	NeuViz 64i,NeuViz 64e	2012-11-20
PMN K121792 | JAK Wang Jun(Mario Wang) [NEUSOFT MEDICAL SYSTEMS CO., LTD.]	NeuViz 64 In, NeuViz 64 En	2012-11-20
PMN K121792 NEUSOFT MEDICAL SYSTEMS CO., LTD.	NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM	2012-11-16
PMN K110077 NEUSOFT MEDICAL SYSTEMS CO., LTD.	NEUCOLONCARE	2011-01-28
PMN K092742 | JAK Wang Jun(Mario Wang) [NEUSOFT MEDICAL SYSTEMS CO., LTD.]	NeuViz 16	2010-11-16
PMN K071308 | JAK Wang Jun(Mario Wang) [NEUSOFT MEDICAL SYSTEMS CO., LTD.]	NeuViz Dual	2010-11-16
PMN K071154 | LNH Wang Jun(Mario Wang) [NEUSOFT MEDICAL SYSTEMS CO., LTD.]	Superstar 0.35T	2010-11-16
PMN K102435 NEUSOFT MEDICAL SYSTEMS CO., LTD.	BEYONDIMAGE WORKSTATION	2010-10-15
PMN K092742 NEUSOFT MEDICAL SYSTEMS CO., LTD.	NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM	2009-09-22
PMN K092237 NEUSOFT MEDICAL SYSTEMS CO., LTD.	NSM-S15 SYSTEM	2009-09-09
PMN K092235 NEUSOFT MEDICAL SYSTEMS CO., LTD.	BEYONDIMAGE WORKSTATION	2009-08-06
PMN K090552 NEUSOFT MEDICAL SYSTEMS CO., LTD.	UROCARE	2009-03-16
PMN K090173 NEUSOFT MEDICAL SYSTEMS CO., LTD.	NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM	2009-02-05
PMN K083877 NEUSOFT MEDICAL SYSTEMS CO., LTD.	FLYING DIAGNOSTIC ULTRASOUND SYSTEM	2009-01-13
PMN K082485 NEUSOFT MEDICAL SYSTEMS CO., LTD.	MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A	2008-09-09
PMN K080540 NEUSOFT MEDICAL SYSTEMS CO., LTD.	NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0	2008-03-13
PMN K071308 NEUSOFT MEDICAL SYSTEMS CO., LTD.	MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM	2007-08-16
PMN K071154 NEUSOFT MEDICAL SYSTEMS CO., LTD.	SUPERSTAR 0.35T MRI SYSTEM	2007-05-10
PMN K062860 NEUSOFT MEDICAL SYSTEMS CO., LTD.	MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A	2006-10-27
PMN K062451 NEUSOFT MEDICAL SYSTEMS CO., LTD.	NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM	2006-09-28
PMN K061132 NEUSOFT MEDICAL SYSTEMS CO., LTD.	MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035	2006-05-24

Similar & Related FDA Registered Companies

• Neusoft Positron Medical Systems Co LTD
• NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020073013699	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	1.5T NANDINA	2 PKG
201907225631	Pusan,South Korea -> Houston, Texas	NEUVIZ 16 ESSENCE MULTI-SLICE SCANNER SYSTEM	6 PKG
2019071683984	Puerto Manzanillo,Panama -> San Juan, Puerto Rico	NEUVIZ 16 ESSENCE MULTI-SLICE SCANNER SYSTEM HS CODE: 902212	5 PKG
2019050620918	Luda,China (Mainland) -> Houston, Texas	NEUVIZ 64IN (300KG) MULTI-SLICE CT SCANNER SYSTEM	5 PKG
201808145567	Pusan,South Korea -> Houston, Texas	NEUVIZ 64IN CT SCANNER SYSTEMN64IN180205E	5 PKG
2018080210595	Pusan,South Korea -> Houston, Texas	NEUVIZ 16 ESSENCE CT SCANNER SYSTEMN16E180047 E	5 PKG
2018071911528	Pusan,South Korea -> Houston, Texas	NEUVIZ 128 CT SCANNER SYSTEMNEUVIZ 64IN CT SC ANNER SYSTEM	11 PKG
201806297927	Ningpo ,China (Mainland) -> Houston, Texas	NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEMN16E16 0021	5 PKG