SET-5002
Shimadzu Corporation Medical Systems Division
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 8030233 | 3002808139 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION | 1 | N | 2026-01-01 | 1,NISHINOKYO KUWABARA-CHO NAKAGYO-KU KYOTO JP 604-8511 |
| 1000125362 | 1000125362 | SHIMADZU MEDICAL SYSTEMS | 1 | Y | 2026-01-01 | 3645 N Lakewood Blvd Long Beach CA US 90808 |
| 3001040364 | 3001040364 | SHIMADZU U.S.A. MANUFACTURING, INC. | 1 | N | 2026-01-01 | 1900 SE 4TH AVE Canby OR US 97013 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 10482 | 1182874945 | K943545 | CEILING SUSPENDED C-ARM SUPPORT MH-100 | IZI | 1995-02-03 |
| 10482 | 1836597725 | K920725 | COLLIMATOR F-20 | IZW | 1992-04-16 |
| 10482 | 1081263772 | K252099 | Trinias | OWB | 2026-03-24 |
| 10482 | 1174181728 | K240827 | SET-5002 | KPS | 2024-05-24 |
| 10482 | 1628542317 | K233722 | RADspeed Pro | KPR | 2024-02-23 |
| 10482 | 2067642151 | K233719 | FDR Visionary Suite | KPR | 2024-03-28 |
| 10482 | 1748689330 | K221922 | Trinias | OWB | 2022-07-28 |
| 10482 | 1278173717 | K203535 | Trinias | OWB | 2021-04-28 |
| 10482 | 1171784433 | K191877 | FLUOROspeed | JAA | 2019-08-05 |
| 10482 | 1388601407 | K173517 | RADspeed fit | KPR | 2018-03-30 |
| 10482 | 1542124823 | K152294 | FDR Visionary Suite | KPR | 2016-07-15 |
| 10482 | 2054452154 | K152244 | RADspeed Pro | KPR | 2016-06-20 |
| 10482 | 1445179453 | K142341 | X-RAY TV SYSTEM SONIALVISION G4 | JAA | 2015-03-06 |
| 10482 | 1670666361 | K131075 | X-RAY TV SYSTEM SONIAL VISION G4 | JAA | 2014-03-28 |
| 10482 | 1752750948 | K123508 | TRINIAS | OWB | 2014-02-26 |
| 10482 | 1486598628 | K101039 | SHIMADZU COLLIMATOR R-300 | IZW | 2010-09-20 |
| 10482 | 1922838454 | K101036 | SHIMADZU COLLIMATOR R-20J | IZX | 2010-08-26 |
| 10482 | 1725223904 | K090578 | SHIMADZU COLLIMATOR R-30H | IZW | 2009-11-06 |
| 10482 | 1170926727 | K090268 | SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION | IZL | 2009-06-30 |
| 10482 | 1660356495 | K080701 | SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION | IZL | 2008-05-14 |
| 10482 | 1304416245 | K072006 | DAR-9400F | IZI | 2007-08-31 |
| 10482 | 1502678595 | K062360 | BRANSIST SAFIRE | IZI | 2006-10-05 |
| 10482 | 1799071603 | K052500 | DAR-8000F | IZI | 2005-10-17 |
| 10482 | 1127760587 | K052076 | DAR-8000I | IZI | 2005-09-02 |
| 10482 | 1985662713 | K050925 | DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE | MQB | 2005-06-01 |
| 10482 | 1182505663 | K043379 | SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 | OXO | 2005-02-17 |
| 10482 | 1957891029 | K041763 | SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES | IZL | 2004-07-13 |
| 10482 | 1288374022 | K040870 | SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS | JAA | 2004-05-17 |
| 10482 | 1889995491 | K033184 | LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400 | IZI | 2003-12-09 |
| 10482 | 1417161556 | K032443 | DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE | IZI | 2004-02-20 |
| 10482 | 1949968093 | K012424 | SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM | JAA | 2001-10-18 |
| 10482 | 1200921400 | ||||
| 10482 | 1319982202 | ||||
| 166542 | 1325660260 | ||||
| 10482 | 1419871279 | ||||
| 10482 | 1837341051 | ||||
| 10482 | 1855824929 | ||||
| 10482 | 1899059790 | ||||
| 166542 | 1939129586 |
Product Codes Associated With Registrations
PMN
FDR Visionary Suite
Shimadzu Corporation
RADspeed Pro
Shimadzu Corporation
Trinias
Shimadzu Corporation Medical Systems Division
Trinias
Shimadzu Corporation Medical Systems
FLUOROspeed
Shimadzu Corporation
SonialVision G4
SHIMADZU Corporation
RADspeed Fit
SHIMADZU Corporation
FDR Visionary Suite
SHIMADZU CORPORATION
RADspeed Pro
SHIMADZU CORPORATION
X-RAY TV SYSTEM SONIALVISION G4
SHIMADZU CORP.
X-RAY TV SYSTEM SONIAL VISION G4
SHIMADZU CORP.
TRINIAS
Shimadzu Corporation
SHIMADZU COLLIMATOR R-300
SHIMADZU CORP.
SHIMADZU COLLIMATOR R-20J
SHIMADZU CORP.
SHIMADZU COLLIMATOR R-30H
SHIMADZU CORP.
SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION
SHIMADZU CORP.
DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
SHIMADZU MEDICAL SYSTEMS
SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION
SHIMADZU CORP.
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
SHIMADZU MEDICAL SYSTEMS
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO
SHIMADZU MEDICAL SYSTEMS
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
SHIMADZU MEDICAL SYSTEMS
DAR-9400F
SHIMADZU CORP.
GE OEC ALTITUDE
SHIMADZU CORP.
BRANSIST SAFIRE
SHIMADZU CORP.
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
SHIMADZU MEDICAL SYSTEMS
ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO
SHIMADZU MEDICAL SYSTEMS
DAR-8000F
SHIMADZU MEDICAL SYSTEMS
DAR-8000I
SHIMADZU MEDICAL SYSTEMS
DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE
SHIMADZU CORP.
ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
SHIMADZU MEDICAL SYSTEMS
SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200
SHIMADZU CORP.
SHIMADZU COLLIMATOR R-20J
SHIMADZU CORP.
SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES
SHIMADZU CORP.
SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS
SHIMADZU CORP.
DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE
SHIMADZU CORP.
LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400
SHIMADZU CORP.
SHIMADZU COLLIMATOR R-30H
SHIMADZU CORP.
SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM
SHIMADZU CORP.
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC
SHIMADZU CORP.
GUDID
SONIALVISION G4 - 503-78000-51
2019-08-14
SONIALVISION G4 - 503-78000-52
2019-08-14
SONIALVISION G4 - 503-78000-53
2019-08-14
SONIALVISION G4 - 566-10000-41
2019-08-14
SONIALVISION G4 - 566-10000-42
2019-08-14
SONIALVISION G4 - 566-10000-43
2019-08-14
SONIALVISION G4 - 566-10000-46
2019-08-14
SONIALVISION G4 - 566-10000-47
2019-08-14
R-20J - 563-55050-31
2020-02-21
Trinias - 503-79831-43
2019-05-31
Trinias - 503-79823-43
2019-05-31
0.7/1.2JG326 D-265 - 582-24825-42
2019-07-23
0.4/0.7JG326 D-265 - 582-24838-11
2019-07-23
Trinias - 503-79830-43
2019-05-31
Trinias - 503-79832-43
2019-05-31
Trinias - 503-79840-43
2019-05-31
0.7/1.2JG326 D-265 - 582-24825-04
2019-07-23
0.6/1.2P324DK-85 - 582-24486-50
2020-02-21
0.6/1.2P324DK-85 - 582-24486-57
2020-02-21
0.6/1.2P13DK-85 - 582-24476-50
2020-02-21
0.6/1.2P33DK-85 - 582-24477-50
2020-02-21
0.6/1.2P33DK-85 - 582-24477-57
2020-02-21
0.6/1.2P38DE-85 - 582-24558-50
2020-02-21
0.6/1.2P38DE-85 - 582-24558-57
2020-02-21
0.6/1.2P364DK-85 - 582-24488-50
2020-02-21
0.6/1.2P364DK-85 - 582-24488-57
2020-02-21
0.6/1.2P324DK-125 - 582-24490-50
2020-02-21
0.6/1.2P324DK-125 - 582-24490-57
2020-02-21
0.6/1.2P364DK-125 - 582-24491-50
2020-02-21
0.6/1.2P364DK-125 - 582-24491-57
2020-02-21
1/2P13DK-85 - 582-24560-50
2020-02-21
1/2P18DK-85 - 582-24480-50
2020-02-21
0.6/1.2P18DE-85 - 582-24556-50
2020-02-21
R-20J - 563-55050-50
2020-02-21
R-20J - 563-55050-60
2020-02-21
UD150B-40 - 565-10274-79
2020-06-05
UD150L-40 - 562-23372-79
2020-06-05
RADspeed Pro - 566-26007-01
2020-06-05
RADspeed Pro - 566-26000-21
2020-06-05
RADspeed Pro - 566-26000-30
2020-06-05