No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00840682109888 | 3.0T HNU | MOS | Coil, magnetic resonance, specialty | 2 | NA | ||
2 | 00840682105378 | SIGNA PET MR | OUO | Tomographic imager combining emission computed tomography with nuclear magnetic resonance | 2 | NA | ||
3 | 00840682105095 | 3.0T GEM PA | LNI,MOS,LNH | System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, speci System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, specialty,System, nuclear magnetic resonance imaging | 2 | NA | ||
4 | 00840682122702 | SIGNA Architect | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
5 | 00840682118187 | 5265300 | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
6 | 00840682118170 | 5265300-3 | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
7 | 00840682147095 | SIGNA Architect | SIGNA Architect System Medical Device Assembly - MDR | LNH | System, nuclear magnetic resonance imaging | 2 | NA | |
8 | 00840682146999 | 6265300 | KXJ | Table, radiologic | 2 | NA | ||
9 | 00840682146395 | 5801659-3 | ECG Patient Cable | IXO | Synchronizer, ECG / respirator, radiographic | 1 | NA | |
10 | 00840682145954 | SIGNA PET MR SPiCE Workstation | OUO | Tomographic imager combining emission computed tomography with nuclear magnetic resonance | 2 | NA | ||
11 | 00840682145770 | SIGNA Pioneer | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
12 | 00840682144261 | 5815748 | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
13 | 00840682102728 | 5265300-20 | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
14 | 00840682135283 | 5789577 | OUO | Tomographic imager combining emission computed tomography with nuclear magnetic resonance | 2 | NA | ||
15 | 00840682135269 | SIGNA Premier | MOS,LNI,LNH | Coil, magnetic resonance, specialty,System, nuclear magnetic resonance spectrosc Coil, magnetic resonance, specialty,System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resonance imaging | 2 | NA | ||
16 | 00840682125697 | 5775930 | OUO | Tomographic imager combining emission computed tomography with nuclear magnetic resonance | 2 | NA | ||
17 | 00840682124591 | MP24 R03 | OUO | Tomographic imager combining emission computed tomography with nuclear magnetic resonance | 2 | NA | ||
18 | 00840682102704 | 5265300-23 | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
19 | 00840682123457 | 5767030-2 | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
20 | 00840682123440 | 5767030 | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
21 | 00840682123129 | SIGNA Artist | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
22 | 00840682121897 | TORSO ARRAY 1.0T | M1887TB | LNH | System, nuclear magnetic resonance imaging | 2 | NA | |
23 | 00840682121620 | GP FLEX COIL SIGNA EXCITE 3.0T | M1385AR | MOS | Coil, magnetic resonance, specialty | 2 | NA | |
24 | 00840682121088 | CARDIAC ARRAY 1.5T 2174499 | MOS | Coil, magnetic resonance, specialty | 2 | NA | ||
25 | 00840682121040 | TORSO ARRAY 1.5T 5154817 | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
26 | 00840682121033 | CARDIAC ARRAY 1.5T 5154685 | MOS | Coil, magnetic resonance, specialty | 2 | NA | ||
27 | 00840682121019 | TORSO ARRAY 1.5T 2215261 | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
28 | 00840682119894 | 5229622 | MOS | Coil, magnetic resonance, specialty | 2 | NA | ||
29 | 00840682119887 | 5229645 | MOS | Coil, magnetic resonance, specialty | 2 | NA | ||
30 | 00840682119870 | 5229625 | MOS | Coil, magnetic resonance, specialty | 2 | NA | ||
31 | 00840682119863 | 5229649 | MOS | Coil, magnetic resonance, specialty | 2 | NA | ||
32 | 00840682119597 | 3.0T GE 6-Channel Phased Array Flex Coil | MOS | Coil, magnetic resonance, specialty | 2 | NA | ||
33 | 00840682119580 | 5363383 | MOS | Coil, magnetic resonance, specialty | 2 | NA | ||
34 | 00840682118965 | DISCOVERY MR 450- 1.5T SPLIT HEAD COIL | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
35 | 00840682118941 | 3.0T SPLIT HEAD COIL | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
36 | 00840682118132 | 5265300-6 | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
37 | 00840682118118 | 5265300-22 | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
38 | 00840682118088 | 5265300-700 | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
39 | 00840682116787 | 5146012 | LNH,LNI,MOS | System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance sp System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, specialty | 2 | NA | ||
40 | 00840682116473 | 3.0T HD 8CH CARDIAC ARRAY | MOS | Coil, magnetic resonance, specialty | 2 | NA | ||
41 | 00840682116145 | 1.5T GP FLEX COIL | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
42 | 00840682116114 | 1.5T SPLIT HEAD COIL | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
43 | 00840682116084 | 5" ROUND COIL 1.5T | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
44 | 00840682116008 | 3" ROUND COIL 1.5T | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
45 | 00840682115964 | G3341AA | LNH,MOS,LNI | System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty,S System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty,System, nuclear magnetic resonance spectroscopic | 2 | NA | ||
46 | 00840682115889 | G3341AB | LNH,MOS,LNI | System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty,S System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty,System, nuclear magnetic resonance spectroscopic | 2 | NA | ||
47 | 00840682114264 | 3.0T 16CH HEAD NECK SPINE HNS ARRAY | MOS | Coil, magnetic resonance, specialty | 2 | NA | ||
48 | 00840682109802 | 3.0T PETMR CMA | OUO | Tomographic imager combining emission computed tomography with nuclear magnetic resonance | 2 | NA | ||
49 | 00840682109741 | 3.0T GEM HNU | MOS,LNI,LNH | Coil, magnetic resonance, specialty,System, nuclear magnetic resonance spectrosc Coil, magnetic resonance, specialty,System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resonance imaging | 2 | NA | ||
50 | 00840682108881 | 3.0T AA | MOS,LNH | Coil, magnetic resonance, specialty,System, nuclear magnetic resonance imaging | 2 | NA |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00868029000360 | 14774 | Medium Torso Coil (Receive Only) – Top | VIEWRAY INCORPORATED | ||
2 | 00868029000353 | 14775 | Head Neck Coil (Receive Only) – Top | VIEWRAY INCORPORATED | ||
3 | 00868029000346 | 20000-01 | MRIdian Linac System | VIEWRAY INCORPORATED | ||
4 | 00868029000315 | 12981 | Medium Torso Coil (Receive Only) – Bottom | VIEWRAY INCORPORATED | ||
5 | 00868029000308 | 11765 | Head Neck Coil (Receive Only) – Bottom | VIEWRAY INCORPORATED | ||
6 | 00867170000106 | VS5060 | Vascular Flow Analysis System | NOVA | VASSOL, INC. | |
7 | 00866613000338 | 4318932 | 2Tx32Rx 7T Head Coil for GE | 2Tx32Rx 7T Head Coil | NOVA MEDICAL, INC | |
8 | 00866613000321 | 38320169 | 3T 32 CH Head Coil | 3T 32 CH Head Coil | NOVA MEDICAL, INC | |
9 | 00866613000314 | 1893279 | 1Tx32Rx 7T Head Coil for Siemens | 1Tx32Rx 7T Head Coil | NOVA MEDICAL, INC | |
10 | 00866613000307 | 3832016 | 3T 32 CH Head Coil device for GE MR750 | 3T 32 CH Head Coil | NOVA MEDICAL, INC | |
11 | 00866463000410 | 1.1 | 200003 | STAGE works as a comprehensive brain imaging post-processing solution. The STAGE STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a dedicated computer connected to the user’s local area network. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e. the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to wherever it received the files from (most likely a PACS server). The STAGE system will not contain any user interface. Instead, the data transfer will be initiated by the user’s current DICOM viewing software. The main method for user communication will be through DICOM output files that contain information in the image data. A method for remote connection to the STAGE computer will be included for updating and troubleshooting when an internet connection is available. | STAGE | SPINTECH, INC. |
12 | 00862694000304 | TMS-MRI-3500wb-02 | PICA Whole-body MRI System | TIME MEDICAL SYSTEMS | ||
13 | 00862694000304 | TMS-MRI-3500wb-02 | PICA Whole-body MRI System | TIME MEDICAL SYSTEMS | ||
14 | 00860008041326 | PBA24GE30A | The InkSpace Imaging Pediatric Body Array is a phased array, receive-only coil i The InkSpace Imaging Pediatric Body Array is a phased array, receive-only coil intended to work with GE 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution pediatric body MR imaging examinations. The size and layout of individual channels of the InkSpace Imaging Pediatric Body Array were designed specifically to fit the pediatric population for body imaging. The coil is comprised of 24 total channels, with two individual flexible pads, intended to be placed anterior and posterior to the patient, containing 12 individual elements. The elements are optimized to be flexible to conform to a pediatric patient’s anatomy. | Pediatric Body Array | INKSPACE IMAGING, INC. | |
15 | 00860006901127 | PR071-001-R | PR071-001-R | Magnetic Resonance Imaging System, Auxiliary Rack | Promaxo MRI System | PROMAXO, INC. |
16 | 00860006901127 | PR071-001-R | PR071-001-R | Magnetic Resonance Imaging System, Auxiliary Rack | Promaxo MRI System | PROMAXO, INC. |
17 | 00860006901110 | PR071-001-M | PR071-001-M | Magnetic Resonance Imaging System, Magnet Cart | Promaxo MRI System | PROMAXO, INC. |
18 | 00860006901110 | PR071-001-M | PR071-001-M | Magnetic Resonance Imaging System, Magnet Cart | Promaxo MRI System | PROMAXO, INC. |
19 | 00860004785101 | v5 | FIRMM® | Framewise Integrated Real-Time MRI Monitoring | FIRMM® | NOUS IMAGING, INC. |
20 | 00860000606172 | 850-11001-05 | Swoop POC MRI Scanner (Mk1.8 version) | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner | HYPERFINE RESEARCH, INC. | |
21 | 00860000606165 | 850-11016-05 | Transmit and Receive Radio Frequency (RF) Head Coil for Use with the Swoop POC M Transmit and Receive Radio Frequency (RF) Head Coil for Use with the Swoop POC MRI Scanner (Mk1.8 version) | Swoop Transmit and Receive Radio Frequency Head Coil | HYPERFINE RESEARCH, INC. | |
22 | 00860000606158 | V2.0 (815-11016-04) | The Transmit and Receive Radio Frequency Head Coil, like RF coils used on conven The Transmit and Receive Radio Frequency Head Coil, like RF coils used on conventional high-field systems (e.g. 1.5T, 3T), is used to transmit RF pulses and to receive MR signals. It consists of one linear mode transmit coil, and an 8-channel receive phased array. | Swoop Transmit and Receive Radio Frequency Head Coil | HYPERFINE RESEARCH, INC. | |
23 | 00860000606141 | V1.7 (850-11001-04) | The Point-Of-Care Magnetic Resonance Imaging (POC MRI) system is an MRI device t The Point-Of-Care Magnetic Resonance Imaging (POC MRI) system is an MRI device that is portable allowing patient bedside imaging. It enables visualization of the internal structures of the head using standard magnetic resonance imaging contrasts. The main interface is a commercial off-the-shelf device, used to operate the system, provide access to patient data, exam set-up, exam execution, and MRI image data viewing for quality control purposes as well as for cloud storage interactions. The POC MRI system can generate MRI data sets with a broad range of contrasts.The user interface includes touch screen menus, controls, indicators and navigation icons that allow the operator to control the system and to view imagery. | Swoop Point-of-Care Magnetic Resonance Imaging Scanner | HYPERFINE RESEARCH, INC. | |
24 | 00860000606134 | V1.0 (810-11049-01) | The Site Quality Assurance Phantom is specifically designed as a medical device The Site Quality Assurance Phantom is specifically designed as a medical device and augments the scanner by allowing weekly quality control checks of the functioning of the scanner in the hospital environment. | Swoop Site Quality Assurance Phantom | HYPERFINE RESEARCH, INC. | |
25 | 00859193006593 | 308GE1500 | ScanMed Elbow Coil | SCANMED, LLC | ||
26 | 00859193006579 | 994SI1501 | ScanMed Orbit and Mandible Coil | SCANMED, LLC | ||
27 | 00859193006463 | 516PH3001 | ScanMed Blanket Coil | SCANMED, LLC | ||
28 | 00859193006456 | 508PH3001 | ScanMed PROCURE™ Coil | SCANMED, LLC | ||
29 | 00859193006449 | 508PH1501 | ScanMed PROCURE™ Coil | SCANMED, LLC | ||
30 | 00859193006432 | 208SI1501 | ScanMed Shoulder/Knee (M) Coil | SCANMED, LLC | ||
31 | 00859193006425 | 588PH3001 | ScanMed PROCURE™ Coil | SCANMED, LLC | ||
32 | 00859193006371 | 588PH1501 | ScanMed PROCURE™ Coil | SCANMED, LLC | ||
33 | 00859193006364 | 318SI3001 | ScanMed High Resolution Wrist Coil | SCANMED, LLC | ||
34 | 00859193006357 | 118SI3001 | ScanMed Ankle Coil | SCANMED, LLC | ||
35 | 00859193006340 | 316GE1501 | ScanMed Elbow Coil | SCANMED, LLC | ||
36 | 00859193006333 | 208SI3001 | ScanMed Shoulder/Knee (M) Coil | SCANMED, LLC | ||
37 | 00859193006326 | 4535-303-62942 | Philips ST SENSE NV 8 NeuroVascular Coil | SCANMED, LLC | ||
38 | 00859193006319 | 308SI3001 | ScanMed Elbow Coil | SCANMED, LLC | ||
39 | 00859193006302 | 308SI1501 | ScanMed Elbow Coil | SCANMED, LLC | ||
40 | 00859193006296 | 308GE3001 | ScanMed Elbow Coil | SCANMED, LLC | ||
41 | 00859193006289 | 308GE1501 | ScanMed Elbow Coil | SCANMED, LLC | ||
42 | 00859193006272 | 208GE3001 | ScanMed Shoulder/Knee (M) Coil | SCANMED, LLC | ||
43 | 00859193006265 | 208GE1501 | ScanMed Shoulder/Knee (M) Coil | SCANMED, LLC | ||
44 | 00859193006258 | 169GE3001 | ScanMed Long Bone (L) Coil | SCANMED, LLC | ||
45 | 00859193006241 | 169GE1501 | ScanMed Long Bone (L) Coil | SCANMED, LLC | ||
46 | 00859193006234 | 168GE3001 | ScanMed Long Bone (M) Coil | SCANMED, LLC | ||
47 | 00859193006227 | 168GE1501 | ScanMed Long Bone (M) Coil | SCANMED, LLC | ||
48 | 00859193006210 | 588SI1501 | ScanMed PROCURE™ Coil | SCANMED, LLC | ||
49 | 00859193006203 | 588GE3001 | ScanMed PROCURE™ Coil | SCANMED, LLC | ||
50 | 00859193006197 | 588GE1501 | ScanMed PROCURE™ Coil | SCANMED, LLC |