| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | B201CGCORE24MR0 | CGCORE24MR | CG-CORE24-MR | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally. | JAK | System, X-Ray, Tomography, Computed | Clear Guide CORE | |
| 2 | B201CGCORE240 | CGCORE24 | CG-CORE24 | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24 model is a panel PC with a 24" screen. | JAK | System, X-Ray, Tomography, Computed | Clear Guide CORE | |
| 3 | B201CGCORE170 | CGCORE17 | CG-CORE17 | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE17 model is a panel PC with a 17" screen. | IYO | System, Imaging, Pulsed Echo, Ultrasonic | Clear Guide CORE | |
| 4 | B201CGCORE130 | CGCORE13 | CG-CORE-13 | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE13 model is a tablet PC with a 13" screen. | JAK | System, X-Ray, Tomography, Computed | Clear Guide CORE | |
| 5 | B201CGVMNS0 | CGVMNS | CG-VM-NS | The device is a sterile or sterilizable (via PVP-I or similar antiseptic) access The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. | JAC | System, X-Ray, Film Marking, Radiographic | Clear Guide VisiMARKER Non-Sterile | |
| 6 | B201CGSCENERGY0 | CGSCENERGY | JAK | System, X-Ray, Tomography, Computed | 2 | Clear Guide SCENERGY | ||
| 7 | B201CGVM2NS0 | CGVM2NS | CG-VM2-NS | The device is a sterile or sterilizable (via PVP-I or similar antiseptic) access The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. | JAC | System, X-Ray, Film Marking, Radiographic | Clear Guide VisiMARKER II Non-Sterile | |
| 8 | B201CGONE0 | CGONE | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Clear Guide ONE | ||
| 9 | B201CGVM20 | CGVM2 | CG-VM2 | The device is a sterile or sterilizable (via PVP-I or similar antiseptic) access The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. | JAC | System, X-Ray, Film Marking, Radiographic | Clear Guide VisiMARKER II | |
| 10 | B201CGVM0 | CGVM | The device is a sterile or sterilizable (via PVP-I or similar antiseptic) access The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. | JAC | System, X-Ray, Film Marking, Radiographic | Clear Guide VisiMARKER | ||
| 11 | B201CGSMM0 | CGSMM | CG-SM-M | The device is a sterile accessory intended to provide a sterile barrier for medi The device is a sterile accessory intended to provide a sterile barrier for medical procedures that require sterility and utilize the Clear Guide SuperPROBE (customer's ultrasound probe with Clear Guide Optical Head). The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. Device is packaged together with one sterile gel packet. | PUI | Drape, Surgical, Exempt | Clear Guide SteriMASK | |
| 12 | B201CGSM0 | CGSM | The device is a sterile accessory intended to provide a sterile barrier for medi The device is a sterile accessory intended to provide a sterile barrier for medical procedures that require sterility and utilize the Clear Guide SuperPROBE (customer's ultrasound probe with Clear Guide Optical Head). The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. | PUI | Drape, Surgical, Exempt | 2 | Clear Guide SteriMASK | |
| 13 | B201CGTT0 | CGTT | JAC | System, X-Ray, Film Marking, Radiographic | Clear Guide TipTAG | |||
| 14 | B201CGOHM0 | CGOHM | CG-OH-M | The device is intended as an accessory hardware to provide input into medical de The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. | IYO,JAK | System, Imaging, Pulsed Echo, Ultrasonic,System, X-Ray, Tomography, Computed | Clear Guide Optical Head |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 08800013543004 | X-CUBE i9 | The X-CUBE i9 diagnostic ultrasound system is intended for use by, or by the ord The X-CUBE i9 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who isqualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; SmallOrgan(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Trans-esoph. (Cardiac); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Color M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD)Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode. The X-CUBE i9 is intended to be used in a hospital or medical clinic. | X-CUBE i9 | ALPINION MEDICAL SYSTEMS CO.,LTD | |
| 2 | 08800013542007 | X-CUBE i8 | The X-CUBE i8 diagnostic ultrasound system is intended for use by, or by the ord The X-CUBE i8 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who isqualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; SmallOrgan(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Trans-esoph. (Cardiac); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Color M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD)Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode. The X-CUBE i8 is intended to be used in a hospital or medical clinic. | X-CUBE i8 | ALPINION MEDICAL SYSTEMS CO.,LTD | |
| 3 | 08800013541000 | X-CUBE 90 | The X-CUBE 90 diagnostic ultrasound system is intended for use by, or by the ord The X-CUBE 90 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate).And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Color M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode.The X-CUBE 90 is intended to be used in a hospital or medical clinic. | X-CUBE 90 | ALPINION MEDICAL SYSTEMS CO.,LTD | |
| 4 | 08800013540003 | X-CUBE 70 | The X-CUBE 70 diagnostic ultrasound system is intended for use by, or by the ord The X-CUBE 70 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate).And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Color M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode.The X-CUBE 70 is intended to be used in a hospital or medical clinic. | X-CUBE 70 | ALPINION MEDICAL SYSTEMS CO.,LTD | |
| 5 | 08800013531001 | minisono C1-6 | minisono | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 6 | 08800013530004 | minisono L3-12 | minisono | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 7 | 08800013528001 | E-CUBE 8 | E-CUBE | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 8 | 08800013527004 | E-CUBE inno | E-CUBE | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 9 | 08800013526007 | E-CUBE i7 | E-CUBE | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 10 | 08800013525000 | E-CUBE 15 | E-CUBE | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 11 | 08800013524003 | E-CUBE 12 | E-CUBE | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 12 | 08800013523006 | E-CUBE 11 | E-CUBE | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 13 | 08800013522009 | E-CUBE 9 | E-CUBE | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 14 | 08800013521002 | E-CUBE 7 | E-CUBE | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 15 | 08800013520005 | E-CUBE 5 | E-CUBE | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 16 | 08800013519047 | CW8.0 | CW8.0 | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 17 | 08800013519023 | CW2.0 | CW2.0 | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 18 | 08800013519016 | CW5.0 | CW5.0 | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 19 | 08800013519009 | TEE3-7 | TEE3-7 | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 20 | 08800013515001 | VE3-10H | VE3-10H | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 21 | 08800013514042 | SVC1-8H | SVC1-8H | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 22 | 08800013514035 | VC1-6T | VC1-6T | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 23 | 08800013514028 | SVC1-6H | SVC1-6H | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 24 | 08800013514011 | VC1-6 | VC1-6 | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 25 | 08800013514004 | SVC1-6 | SVC1-6 | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 26 | 08800013513120 | EV2-11H | EV2-11H | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 27 | 08800013513113 | EC2-11H | EC2-11H | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 28 | 08800013513106 | EC3-10X | EC3-10X | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 29 | 08800013513090 | EV3-10X | EV3-10X | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 30 | 08800013513083 | EV3-10T | EV3-10T | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 31 | 08800013513076 | EC3-10T | EC3-10T | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 32 | 08800013513069 | EC3-10H | EC3-10H | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 33 | 08800013513052 | EV3-10H | EV3-10H | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 34 | 08800013513045 | EV3-10 | EV3-10 | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 35 | 08800013513038 | EC3-10 | EC3-10 | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 36 | 08800013513021 | E3-10H | E3-10H | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 37 | 08800013513014 | EN3-10 | EN3-10 | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 38 | 08800013513007 | E3-10 | E3-10 | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 39 | 08800013512109 | SP4-12 | SP4-12 | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 40 | 08800013512093 | P1-5CT | P1-5CT | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 41 | 08800013512079 | SP1-5T | SP1-5T | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 42 | 08800013512062 | SP3-8T | SP3-8T | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 43 | 08800013512055 | MP1-5X | MP1-5X | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 44 | 08800013512048 | SPN1-5X | SPN1-5X | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 45 | 08800013512031 | SP1-5X | SP1-5X | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 46 | 08800013512024 | SP1-5i | SP1-5i | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 47 | 08800013512017 | SP3-8 | SP3-8 | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 48 | 08800013512000 | SP1-5 | SP1-5 | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 49 | 08800013511171 | C1-6C | C1-6C | ALPINION MEDICAL SYSTEMS CO.,LTD | ||
| 50 | 08800013511164 | C1-7GT | C1-7GT | ALPINION MEDICAL SYSTEMS CO.,LTD |