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 | 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 | |
9 | 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 | ||
10 | 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 | |
11 | 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 | |
12 | B201CGTT0 | CGTT | JAC | System, X-Ray, Film Marking, Radiographic | Clear Guide TipTAG | |||
13 | 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 | |
14 | B201CGOH0 | CGOH | CG-OH | 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 | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Clear Guide Optical Head |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
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1 | 06948941160015 | MD-6000P | MD-6000P Bladder Scanner is a hand-held ultrasonic equipment with built-in 3D me MD-6000P Bladder Scanner is a hand-held ultrasonic equipment with built-in 3D mechanical sector scan probe. It is intended to measure the urine volume in human bladder. It can be connected with Tablet PC through Wi-Fi connection for medical record data transmission and management. | Bladder Scanner | MEDA CO., LTD | |
2 | 06948941160008 | MD-6000 | MD-6000 Bladder Scanner is a portable battery-operated ultrasonic equipment of p MD-6000 Bladder Scanner is a portable battery-operated ultrasonic equipment of pulse reflection. It utilizes ultrasonic distance measuring principle to measure the volume of bladder filled with urine. | Bladder Scanner | MEDA CO., LTD | |
3 | 06948941132005 | MD-320W | MD-320W Ultrasound Biomicroscope is an ultrasonic imaging system with high-resol MD-320W Ultrasound Biomicroscope is an ultrasonic imaging system with high-resolution. It is intended to be used in clinical ophthalmology for ultrasonic diagnosis on the anterior segment of eyes. | Ultrasound Biomicroscope | MEDA CO., LTD | |
4 | 06948941111123 | MD-1000A/P | MD-1000A/P Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medi MD-1000A/P Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medical device based on pulse reflection. It’s intended for measurements of biometric parameters and corneal thickness. | Ultrasonic Biometer for Ophthalmology | MEDA CO., LTD | |
5 | 06948941111116 | MD-1000P | MD-1000P Ultrasonic Pachymeter is an ultrasonic measuring medical device based o MD-1000P Ultrasonic Pachymeter is an ultrasonic measuring medical device based on pulse reflection. It’s intended for measurements of corneal thickness. | Ultrasonic Pachymeter | MEDA CO., LTD | |
6 | 06948941111109 | MD-1000A | MD-1000A Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medica MD-1000A Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medical device based on pulse reflection. It’s intended for measurements of biometric parameters. | Ultrasonic Biometer for Ophthalmology | MEDA CO., LTD | |
7 | 06948941102237 | MD-2300S | MD-2300S Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medic MD-2300S Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medical device intended for ophthalmological ultrasonic diagnosis and biometric measurement. | Ultrasonic A/B Scanner for Ophthalmology | MEDA CO., LTD | |
8 | 06948941102220 | ODM-2200 | ODM-2200 Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medic ODM-2200 Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medical device intended for ophthalmological ultrasonic diagnosis and biometric measurement. | Ultrasonic A/B Scanner for Ophthalmology | MEDA CO., LTD | |
9 | 06948941102213 | ODM-2100 | ODM-2100 Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medic ODM-2100 Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medical device intended for ophthalmological ultrasonic diagnosis and biometric measurement. | Ultrasonic A/B Scanner for Ophthalmology | MEDA CO., LTD | |
10 | 06945868699055 | S9 Pro | S9 Pro Portable Digital Color Doppler Ultrasound System (With 3P1 and L742 Transducers) | SonoScape | SONOSCAPE MEDICAL CORP. | |
11 | 06945868699048 | S8 Exp | S8 Exp Portable Digital Color Doppler Ultrasound System (With 3C-A and L741 Transducers) | SonoScape | SONOSCAPE MEDICAL CORP. | |
12 | 06945868699031 | S9 | S9 Portable Digital Color Doppler Ultrasound System (With 4P-A and L742 Transducers) | SonoScape | SONOSCAPE MEDICAL CORP. | |
13 | 06945868699024 | S9 Pro | S9 Pro Portable Digital Color Doppler Ultrasound System | SonoScape | SONOSCAPE MEDICAL CORP. | |
14 | 06945868699017 | S8 Exp | S8 Exp Portable Digital Color Doppler Ultrasound System | SonoScape | SONOSCAPE MEDICAL CORP. | |
15 | 06945868699000 | S9 | S9 Portable Digital Color Doppler Ultrasound System | SonoScope | SONOSCAPE MEDICAL CORP. | |
16 | 06945868698010 | S8 | S8 Diagnostic Ultrasound System (With C362 and L742 Transducers) | SonoScape | SONOSCAPE MEDICAL CORP. | |
17 | 06945868698003 | S8 | S8 Diagnostic Ultrasound System | SonoScape | SONOSCAPE MEDICAL CORP. | |
18 | 06945868696016 | S6 | S6 Diagnostic Ultrasound System (With L741 and C344 Transducers) | SonoScape | SONOSCAPE MEDICAL CORP. | |
19 | 06945868696009 | S6 | S6 Diagnostic Ultrasound System | SonoScape | SONOSCAPE MEDICAL CORP. | |
20 | 06945868695507 | X6 Pro | X6 Pro Digital Color Doppler Ultrasound System | SonoScape | SONOSCAPE MEDICAL CORP. | |
21 | 06945868695408 | X6 Exp | X6 Exp Digital Color Doppler Ultrasound System | SonoScape | SONOSCAPE MEDICAL CORP. | |
22 | 06945868695309 | X6 | X6 Digital Color Doppler Ultrasound System | SonoScape | SONOSCAPE MEDICAL CORP. | |
23 | 06945868695200 | X5 Pro | X5 Pro Digital Color Doppler Ultrasound System | SonoScape | SONOSCAPE MEDICAL CORP. | |
24 | 06945868695101 | X5 Exp | X5 Exp Digital Color Doppler Ultrasound System | SonoScape | SONOSCAPE MEDICAL CORP. | |
25 | 06945868695040 | E5 Pro | E5 Pro Series Digital Color Doppler Ultrasound System | Sonoscape | SONOSCAPE MEDICAL CORP. | |
26 | 06945868695033 | E5 Exp | E5 Exp Series Digital Color Doppler Ultrasound System | Sonoscape | SONOSCAPE MEDICAL CORP. | |
27 | 06945868695026 | E1 | E1 Series Digital Color Doppler Ultrasound System | Sonoscape | SONOSCAPE MEDICAL CORP. | |
28 | 06945868695019 | E5 | E5 Series Digital Color Doppler Ultrasound System | Sonoscape | SONOSCAPE MEDICAL CORP. | |
29 | 06945868695002 | X5 | X5 Digital Color Doppler Ultrasound System | SonoScape | SONOSCAPE MEDICAL CORP. | |
30 | 06945868693060 | X3 Pro | X3 Pro Digital Color Doppler Ultrasound System | SonoScape | SONOSCAPE MEDICAL CORP. | |
31 | 06945868693053 | X3 Exp | X3 Exp Digital Color Doppler Ultrasound System | SonoScape | SONOSCAPE MEDICAL CORP. | |
32 | 06945868693046 | X3 | X3 Digital Color Doppler Ultrasound System | SonoScape | SONOSCAPE MEDICAL CORP. | |
33 | 06945868693039 | E3 Pro | E3 Pro Series Digital Color Doppler Ultrasound System | Sonoscape | SONOSCAPE MEDICAL CORP. | |
34 | 06945868693022 | E3 | E3 Series Digital Color Doppler Ultrasound System | Sonoscape | SONOSCAPE MEDICAL CORP. | |
35 | 06945868693015 | E3 Exp | E3 Exp Series Digital Color Doppler Ultrasound System | Sonoscape | SONOSCAPE MEDICAL CORP. | |
36 | 06945868692025 | E2 | E2 Series Digital Color Doppler Ultrasound System | Sonoscape | SONOSCAPE MEDICAL CORP. | |
37 | 06945868692018 | E2 Pro | E2 Pro Series Digital Color Doppler Ultrasound System | Sonoscape | SONOSCAPE MEDICAL CORP. | |
38 | 06945868692001 | E2 Exp | E2 Exp Series Digital Color Doppler Ultrasound System | Sonoscape | SONOSCAPE MEDICAL CORP. | |
39 | 06945868691035 | X1 Pro | X1 Pro Digital Color Doppler Ultrasound System | SonoScape | SONOSCAPE MEDICAL CORP. | |
40 | 06945868691028 | X1 | X1 Digital Color Doppler Ultrasound System | SonoScape | SONOSCAPE MEDICAL CORP. | |
41 | 06945868691011 | E1 Pro | E1 Pro Series Digital Color Doppler Ultrasound System | Sonoscape | SONOSCAPE MEDICAL CORP. | |
42 | 06945868691004 | E1 Exp | E1 Exp Series Digital Color Doppler Ultrasound System | Sonoscape | SONOSCAPE MEDICAL CORP. | |
43 | 06945868680015 | SSI-8000 | SSI-8000 Mobile Digital Color Doppler Ultrasound System (With C362 and L743 Transducers) | SonoScape | SONOSCAPE MEDICAL CORP. | |
44 | 06945868680008 | SSI-8000 | SSI-8000 Mobile Digital Color Doppler Ultrasound System | SonoScape | SONOSCAPE MEDICAL CORP. | |
45 | 06945868622091 | C613 | C613 Ultrasonic Transducer (E5) | SonoScape | SONOSCAPE MEDICAL CORP. | |
46 | 06945868620899 | C322 | C322 Ultrasonic Transducer (X5 Series) | SonoScape | SONOSCAPE MEDICAL CORP. | |
47 | 06945868620141 | 3P-A | 3P-A Ultrasonic Transducer (E5) | SonoScape | SONOSCAPE MEDICAL CORP. | |
48 | 06945868620134 | 6V1 | 6V1 Ultrasonic Transducer (E5) | SonoScape | SONOSCAPE MEDICAL CORP. | |
49 | 06945868616106 | S60 Maso | S60 Maso Digital Color Doppler Ultrasound System | Sonoscape | SONOSCAPE MEDICAL CORP. | |
50 | 06945868616090 | S60 VO | S60 VO Digital Color Doppler Ultrasound System | Sonoscape | SONOSCAPE MEDICAL CORP. |