No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 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 | |
2 | 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 | |
3 | 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 | |
4 | 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 | |
5 | B201CGSCENERGY0 | CGSCENERGY | JAK | System, X-Ray, Tomography, Computed | 2 | Clear Guide SCENERGY | ||
6 | 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 | |
7 | B201CGONE0 | CGONE | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Clear Guide ONE | ||
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 |
---|---|---|---|---|---|---|
1 | 00195278592309 | Legend | OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY | Omni | G E MEDICAL SYSTEMS ISRAEL LTD. | |
2 | 00195278469700 | Apex Select | B7919QT-B7919QS | Revolution Apex Select - Designated System Medical Device | Revolution | HANGWEI GE MEDICAL SYSTEMS CO., LTD. |
3 | 00195278454218 | Legend | OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY | Omni | GE MEDICAL SYSTEMS, INC. | |
4 | 00195278403087 | Eagle | Revolution Eagle designated medical device | Revolution | HANGWEI GE MEDICAL SYSTEMS CO., LTD. | |
5 | 00195278385215 | Advance | Revolution Advance designated medical device | Revolution | HANGWEI GE MEDICAL SYSTEMS CO., LTD. | |
6 | 00195278363947 | 1.0 | MaxFOV 2 Application Container for Smart Subscription | MaxFOV 2 | HANGWEI GE MEDICAL SYSTEMS CO., LTD. | |
7 | 00195278362247 | Frontier ES | Revolution Frontier ES for EOL CT Designated medical device | Revolution | HANGWEI GE MEDICAL SYSTEMS CO., LTD. | |
8 | 00195278362230 | Frontier MDR | Revolution Frontier for EOL CT Designated medical device | Revolution | HANGWEI GE MEDICAL SYSTEMS CO., LTD. | |
9 | 00195278303219 | 1.1 | MAR Application Container for Smart Subscription | MAR | GE HEALTHCARE JAPAN CORPORATION | |
10 | 00195278303202 | 1.1 | DLIR Application Container for Smart Subscription | DLIR | GE HEALTHCARE JAPAN CORPORATION | |
11 | 00195278303196 | 1.1 | ASiR-V Application Container for Smart Subscription | ASiR-V | GE HEALTHCARE JAPAN CORPORATION | |
12 | 00195278118295 | H3911AB | STARGATE NM GANTRY FINAL | StarGuide | G E MEDICAL SYSTEMS ISRAEL LTD. | |
13 | 00195278098603 | MI | PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manuf PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manufacturing Make | Discovery | GE MEDICAL SYSTEMS, INC. | |
14 | B887VC110030PL0 | VC-110-030-PL | VC-110-030-PL | 1.10mm x 3.0cm VISICOIL loaded in an 17 gauge brachytherapy needle. | VISICOIL | RADIOMED CORP |
15 | B887VC110020PL300 | VC-110-020-PL30 | VC-110-020-PL30 | 1.10mm x 2.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
16 | B887VC110020PL0 | VC-110-020-PL | VC-110-020-PL | 1.10mm x 2.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
17 | B887VC110010PL300 | VC-110-010-PL30 | VC-110-010-PL30 | 1.10mm x 1.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
18 | B887VC110010PL0 | VC-110-010-PL | VC-110-010-PL | 1.10mm x 1.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
19 | B887VC110005PL0 | VC-110-005-PL | VC-110-005-PL | 1.10mm x 0.5cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
20 | B887VC075030PL0 | VC-075-030-PL | VC-075-030-PL | 0.75mm x 3.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
21 | B887VC075020PL300 | VC-075-020-PL30 | VC-075-020-PL30 | 0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
22 | B887VC075020PL120 | VC-075-020-PL12 | VC-075-020-PL12 | 0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
23 | B887VC075020PL0 | VC-075-020-PL | VC-075-020-PL | 0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
24 | B887VC075010PL300 | VC-075-010-PL30 | VC-075-010-PL30 | 0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
25 | B887VC075010PL120 | VC-075-010-PL12 | VC-075-010-PL12 | 0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
26 | B887VC075010PL0 | VC-075-010-PL | VC-075-010-PL | 0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
27 | B887VC075005PL300 | VC-075-005-PL30 | VC-075-005-PL30 | 0.75mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
28 | B887VC075005PL120 | VC-075-005-PL12 | VC-075-005-PL12 | 0.75mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
29 | B887VC075005PL0 | VC-075-005-PL | VC-075-005-PL | 0.75mm x 0.50cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
30 | B887VC050020PLSL0 | VC-050-020-PLSL | VC-050-020-PLSL | 0.50mm x 2.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
31 | B887VC050020PL0 | VC-050-020-PL | VC-050-020-PL | 0.5mm x 2.0cm VISICOIL loaded in a 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
32 | B887VC050010PLSL0 | VC-050-010-PLSL | VC-050-010-PLSL | 0.5mm x 1.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
33 | B887VC050010PL300 | VC-050-010-PL30 | VC-050-010-PL30 | 0.5mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
34 | B887VC050010PL0 | VC-050-010-PL | VC-050-010-PL | 0.50mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
35 | B887VC050005PLSL0 | VC-050-005-PLSL | VC-050-005-PLSL | 0.50mm x 0.5cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
36 | B887VC050005PL300 | VC-050-005-PL30 | VC-050-005-PL30 | 0.50mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
37 | B887VC050005PL0 | VC-050-005-PL | VC-050-005-PL | 0.50mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
38 | B887VC035040PL0 | VC-035-040-PL | VC-035-040-PL | 0.35mm x 4.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
39 | B887VC035030PL0 | VC-035-030-PL | VC-035-030-PL | 0.35mm x 3.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
40 | B887VC035020PL0 | VC-035-020-PL | VC-035-020-PL | 0.35mm x 2.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
41 | B887VC035010PL0 | VC-035-010-PL | VC-035-010-PL | 0.35mm x 1.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
42 | B887VC035005PL0 | VC-035-005-PL | VC-035-005-PL | 0.35mm x 0.5cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
43 | B887SNMR03503022200 | SNMR-035-030-2220 | SNMR-035-030-2220 | 0.35mm x 3.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle. | VISICOIL MR | RADIOMED CORP |
44 | B887SNMR03502022200 | SNMR-035-020-2220 | SNMR-035-020-2220 | 0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle. | VISICOIL MR | RADIOMED CORP |
45 | B887SNMR03502022150 | SNMR-035-020-2215 | SNMR-035-020-2215 | 0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachyt 0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle. | VISICOIL MR | RADIOMED CORP |
46 | B887SNMR03502022080 | SNMR-035-020-2208 | SNMR-035-020-2208 | 0.35mm x 2.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 8cm needle. | VISICOIL MR | RADIOMED CORP |
47 | B887SNMR03501022200 | SNMR-035-010-2220 | SNMR-035-010-2220 | 0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle. | VISICOIL MR | RADIOMED CORP |
48 | B887SNMR03501022150 | SNMR-035-010-2215 | SNMR-035-010-2215 | 0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachyt 0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle. | VISICOIL MR | RADIOMED CORP |
49 | B887SNMR03501022080 | SNMR-035-010-2208 | SNMR-035-010-2208 | 0.35mm x 1.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 8cm needle. | VISICOIL MR | RADIOMED CORP |
50 | B887SN050020PL150 | SN-050-020-PL15 | SN-050-020-PL15 | 0.50mm x 2.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |