BSC

Product ID Part # Description 510K # or FDA # Document

REFERENCE DOCS
N/A uSmart-3200T-PM Letter uSmart-3200T-PM Letter N/A uSmart_3200T PM Letter_9-1-2023
N/A HITACHI_STERIS Revital-Ox Resert HITACHI_STERIS Revital-Ox Resert N/A HITACHI_STERIS Revital-Ox Resert
N/A uSmart-8BP4-User Manual uSmart-8BP4-User Manual N/A uSmart_8BP4_User Manual
N/A uSmart-3200T-QRG uSmart-3200T-Quick Reference Guide N/A uSmart_3200T QRG
N/A uSmart-Transducer Disinfection uSmart-Transducer Disinfection Info N/A uSmart-Transducer Disinfection Info
N/A C41L47RP-User Manual C41L47RP-User Manual N/A HITACHI_C41L47RP_User Manual
N/A Arietta 65-QRG Arietta 65-Quick Reference Guide N/A HITACHI_Arietta 65_QRG
N/A HITACHI_Cleaners, Disinfectants, Sterilization HITACHI_Cleaners, Disinfectants, Sterilization Info N/A HITACHI_Cleaners, Disinfectants, Sterilization Info

HITACHI
6234157 ARIETTA65-URO ARIETTA65-URO K181376 HITACHI_Arietta 65_User Manual
9531357 ARIETTA PRECISION-URO ARIETTA PRECISION-URO ULTRASOUND SYSTEM K163505 HITACHI_Arietta Precision_User Manual
9659965 ARIETTA PRECISION-SE ARIETTA PRECISION-SE ULTRASOUND SYSTEM K163505 HITACHI_Arietta Precision_User Manual
7887794 C41L47RP Probe, URO, BPL, C/L, 8-4, 10-5 Mhz, C41L47RP K191233 HITACHI_C41L47RP_User Manual
4320584 C41V Probe, URO, Conv, End-Fire Prostate, 8-4 Mhz, C41V K163505 HITACHI_C41V_User Manual
6801313 L64 Probe, GEN, Linear, 38mm, 18-5 Mhz, L64 K163505 HITACHI_L64_User Manual
7904865 L55 Probe, GEN/URO, Linear, 50mm, 13-5 Mhz, L55 K181376 HITACHI_L55_User Manual
1248547 CC41R Probe, URO, BPL, C/C, 8-4 Mhz, CC41R K183456 HITACHI_CC41R_User Manual
5223680 L53K Probe, GEN/IOUS, Linear, Hockey-Stick, 15-3 Mhz, L53K K163505 HITACHI_L53K_User Manual
5471123 C251 Probe, GEN, Conv, Abdominal, 5-1 Mhz, C251 K163505 HITACHI_C251_User Manual
5377860 C22P Probe, GEN, Conv, Micro, 6-1 Mhz, C22P K163505 HITACHI_C22P_User Manual
3511498 L43K Probe, IOUS, Linear, Robotic, 12-2 Mhz, L43K K163505 HITACHI_L43K_User Manual
6297810 L51K Probe, IOUS, Linear, Sm Robotic, 15-3 Mhz, L51K K163505 HITACHI_L51K_User Manual
3237339 MP-2819 THREE PEDAL FOOT SWITCH K163505 HITACHI_MN1-6438
9764661 UP-X898MD HYBRID SONY B/W PRINTER N/A Accessory UP-X898MD_C-221-100-13
5120147 MEDIUM-TRAY ASP Sterilization Tray ASP - Medium N/A Accessory

uSMART
5963014 uSmart-3200T-BSC uSmart-3200T-BSC Ultrasound System K193510 uSmart_16-3301-15_V1
uSmart_16-3301-15_V2
TBD uSmart-3300-BSC uSmart-3300-BSC Ultrasound System K150148 uSmart_16-3311-08_V1
uSmart_16-3311-08_V2
4537251 uSmart-8BP4 Probe, URO, BPL, C/L, 8-4, 9-5 Mhz, uSmart-8BP4 K112953 uSmart_8BP4_User Manual
5129564 uSmart-10EC4 Probe, URO, Conv, EF Prostate, 10-4 Mhz, uSmart-10EC4 K193510 uSmart_16-3301-15_V2
3872931 uSmart-15L4 Probe, GEN, Linear, Small Parts, 15-4 Mhz, uSmart-15L4 K150533 uSmart_16-3301-15_V2
1576739 uSmart-5C2 Probe, GEN, Conv, Abdominal, 5-2 Mhz, uSmart-5C2 K150533 uSmart_16-3301-15_V2
2156874 uSmart-16L5 Probe, GEN, Linear, Small Parts, 50mm, 16-5 Mhz, uSmart-16L5 K193510 uSmart_16-3301-15_V2
9845101 uSmart-9MC3 Probe, GEN, Conv, Micro, 9-3 Mhz, uSmart-9MC3 K150533 uSmart_16-3301-15_V2
7582629 uSmart-16HL7 Probe, GEN, Linear, Hockey-Stick, 16-7 Mhz, uSmart-16HL7 K150533 uSmart_16-3301-15_V2
2595417 uSmart-3200T FootSwitch uSmart-Foot Switch N/A Accessory uSmart_16-3301-15_V1
1606084 uSmart-Dicom uSmart-Dicom K193510 uSmart_16-3301-15_V1
9764661 UP-X898MD HYBRID SONY B/W PRINTER N/A Accessory UP-X898MD_C-221-100-13
8584488 uSmart-3200T Cart uSmart-3200T Cart N/A Accessory uSmart_16-3301-15_V1
1634034 uSmart-3200T Multi-Port uSmart-3200T Multi-Port N/A Accessory uSmart_16-3301-15_V1
5810119 uSmart-3200T Power uSmart-3200T Power Supply N/A Accessory uSmart_16-3301-15_V1
3030145 uSmart-3300-Cart uSmart-3300-Cart N/A Accessory uSmart_16-3311-08_V1
6865247 uSmart-3300-Multi-Port uSmart-3300-Multi-Port N/A Accessory uSmart_16-3311-08_V1

DK MEDICAL

DK-SpaceOAR - Kits
5301145 HW-DK-Usmart SPACEOAR KIT-DK-HITACHI/HW-DK-Usmart SPACEOAR FDA: 892.5650 DK_BT-00-000-01-EN-0248
5982202 HW-DK-HITACHI SPACEOAR KIT-DK-uSmart/HW-DK-HITACHI SPACEOAR FDA: 892.5650 DK_BT-00-000-01-EN-0248

SpaceOAR
4244953 HW-100-001 DK-ARM/HW-100-001 FDA: 892.5650 DK_BT-00-000-01-EN-0248
6363574 HW-DKNAFS DK-FLOOR STAND/HW-DKNAFS FDA: 892.5650 DK_BT-00-000-01-EN-0248
8532014 HW-002-003 DK-BASIC STEPPER/HW-002-003 FDA: 892.5650 DK_BT-00-000-01-EN-0248
8483021 HW-002-009 DK-CRADLE-uSmart/HW-002-009 FDA: 892.5650 DK_BT-00-000-01-EN-0248
3678629 HW-002-010 DK-CRADLE-HITACHI/HW-002-010 FDA: 892.5650 DK_BT-00-000-01-EN-0248
7955627 HW-Sleeve DK-PROBE SLEEVE/HW-SLEEVE FDA: 892.5650 DK_BT-00-000-01-EN-0248

Brachy
5950014 HW-002-009-BR DK-CRADLE-uSmart/HW-002-009-BR FDA: 892.5650 DK_BT-00-000-17-EN-0063
9560124 HW-002-010-BR DK-CRADLE-HITACHI/HW-002-010-BR FDA: 892.5650 DK_BT-00-000-17-EN-0063
5953551 HW-002-022 DK-TEMPLATE HOLDER/HW-002-022 FDA: 892.5650 DK_BT-00-000-17-EN-0063

CIVCO

Civco-SpaceOAR - Kits
TBD CIVCO-Usmart SPACEOAR KIT-CIVCO-HITACHI/CIVCO-Usmart SPACEOAR K131161 CIVCO_436595
TBD CIVCO-HITACHI SPACEOAR KIT-CIVCO-uSmart/CIVCO-HITACHI SPACEOAR K131161 CIVCO_436595
CIVCO_436594

MPWS - SpaceOAR
6235104 CIVCO-610-974 Civco Multipurpose Workstation Stabilizer Floor Mount K131161 CIVCO_436595
5102014 CIVCO-610-975 Civco Multipurpose Workstation Stabilizer Table Mount K131161 CIVCO_436595
3068479 CIVCO-683-006 Civco Multipurpose Workstation Stepper & Cradle for 8BP4 probe K131161 CIVCO_436595
4962354 CIVCO-683-005 Civco Multipurpose Workstation Cradle for 8BP4 probe K131161 CIVCO_43786
2035954 CIVCO-644-066 Civco Multipurpose Workstation Stepper & Cradle for Hitachi Probe K131161 CIVCO_436594
8620301 CIVCO-644-085 Civco Multipurpose Workstation Cradle for Hitachi Probe K131161 CIVCO_43786

Classic - Brachy
3532694 CIVCO-644-064 Civco Classic Stepper & Cradle for Hitachi probe K131161 CIVCO_436592
6299532 CIVCO-644-087 Civco Classic Cradle for Hitachi Probe K131161 CIVCO_43755

EX3 - Brachy (Tracked)
4847817 CIVCO-644-081 Civco EX3 Stepper & Cradle for Hitachi probe K131161 CIVCO_436591
5823495 CIVCO-644-089 Civco EX3 Cradle for Hitachi Probe K131161 CIVCO_43812
6326588 CIVCO-683-003 Civco EX3 Stepper & Cradle for 8BP4 probe K131161 CIVCO_436591
9599620 CIVCO-683-004 Civco EX3 Cradle for 8BP4 Probe K131161 CIVCO_43812

Classic & EX3
3356857 CIVCO-610-911 Civco Micro Touch Stabilizer Dual Mount K131161 CIVCO_436593
9329139 CIVCO-610-911S Civco Micro Touch Storage Stand Dual N/A Accessory CIVCO_43763
7342449 CIVCO-610-912 Civco Micro Touch Stabilizer Right Mount K131161 CIVCO_436593
5239550 CIVCO-612-912S Civco Micro Touch Storage Stand Right N/A Accessory CIVCO_43763
1259841 CIVCO-610-913 Civco Micro Touch Stabilizer Left Mount K131161 CIVCO_436593
6201094 CIVCO-610-913S Civco Micro Touch Storage Stand Left N/A Accessory CIVCO_43763