| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 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. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Swoop Point-of-Care Magnetic Resonance Imaging Scanner | |
| 2 | 00860000606189 | Version 1.0 | LLZ | System, Image Processing, Radiological | 2 | BrainInsight | ||
| 3 | 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) | MOS | Coil, Magnetic Resonance, Specialty | 2 | Swoop Transmit and Receive Radio Frequency Head Coil | |
| 4 | 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. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Swoop Site Quality Assurance Phantom | |
| 5 | 00860000606172 | 850-11001-05 | Swoop POC MRI Scanner (Mk1.8 version) | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 08165890202018 | 20562 | ATR002 | Board Riser | AtamAâ„¢ System | MONTERIS MEDICAL INC |
| 2 | 08056304453396 | 9102000000 | Coil for Artoscan | WIRING BASE COIL N.5 | ESAOTE SPA | |
| 3 | 08056304453365 | 9102373001 | Coil for E-scan XQ | SERVICE DPA SHOULDER COIL N.7 | ESAOTE SPA | |
| 4 | 08056304453358 | 9102373000 | Coil for E-scan XQ | DPA SHOULDER COIL N.7 | ESAOTE SPA | |
| 5 | 08056304453341 | 9102313001 | Coil for E-scan XQ | SERVICE MULTIPURPOSE FLEXIBLE COIL N.6 | ESAOTE SPA | |
| 6 | 08056304453334 | 9102313000 | Coil for E-scan XQ | MULTIPURPOSE FLEXIBLE COIL N.6 | ESAOTE SPA | |
| 7 | 08056304453327 | 9102206001 | Coil for E-scan XQ | SERVICE SHOULDER COIL N.5 | ESAOTE SPA | |
| 8 | 08056304453310 | 9102206000 | Coil for E-scan XQ | SHOULDER COIL N.5 | ESAOTE SPA | |
| 9 | 08056304453303 | 9101913001 | Coil for E-scan, Opera | SERVICE KIT ANKLE COIL N.4 | ESAOTE SPA | |
| 10 | 08056304453297 | 9101913000 | Coil for E-scan, Opera | FOOT/ANKLE COIL N.4 | ESAOTE SPA | |
| 11 | 08056304453280 | 9101912001 | Coil for E-scan, Opera | SERVICE KIT COIL N.3 | ESAOTE SPA | |
| 12 | 08056304453273 | 9101912000 | Coil for E-scan, Opera | HAND/WRIST COIL N.3 | ESAOTE SPA | |
| 13 | 08056304453266 | 9101824001 | Coil for E-scan, Opera | SERVICE KIT KNEE COIL N.2 | ESAOTE SPA | |
| 14 | 08056304453259 | 9101824000 | Coil for E-scan, Opera | KNEE COIL N.2 | ESAOTE SPA | |
| 15 | 08056304453242 | 9101819001 | Coil for E-scan, Opera | SERVICE KIT COIL N.1 | ESAOTE SPA | |
| 16 | 08056304453235 | 9101819000 | Coil for E-scan, Opera | SHOULDER COIL N.1 | ESAOTE SPA | |
| 17 | 08056304453228 | 9101645000 | Coil for C-scan | DPA ANKLE COIL N.5 | ESAOTE SPA | |
| 18 | 08056304453211 | 9101644000 | Coil for C-scan | DPA KNEE COIL N.4 | ESAOTE SPA | |
| 19 | 08056304453204 | 9101643000 | Coil for C-scan | DPA HAND/WRIST COIL | ESAOTE SPA | |
| 20 | 08056304453198 | 9101585000 | Coil for C-scan | RF COIL N.1 (KNEE) | ESAOTE SPA | |
| 21 | 08056304453181 | 9101584000 | Coil for C-scan | COIL N.3 (UPPER LIMB) | ESAOTE SPA | |
| 22 | 08056304453174 | 9101034001 | Coil for C-scan | LARGE RF COIL N.2 (KNEE) | ESAOTE SPA | |
| 23 | 08056304453167 | 9101034000 | Coil for Artoscan | COIL N.2 LARGE | ESAOTE SPA | |
| 24 | 08056304452900 | 131001000 | Coil for G-scan | LUMBAR COIL N. 18 | ESAOTE SPA | |
| 25 | 08056304452894 | 131000900 | Coil for G-scan | LUMBAR COIL N. 17 | ESAOTE SPA | |
| 26 | 08056304452887 | 131000401 | Coil for G-scan Brio Service | CERVICAL COIL N.9 SERV | ESAOTE SPA | |
| 27 | 08056304452870 | 131000400 | Coil for G-scan Brio | CERVICAL COIL N.9 | ESAOTE SPA | |
| 28 | 08056304452832 | 9102693101 | CERVICAL COIL N.9 SERV | ESAOTE SPA | ||
| 29 | 08056304452825 | 9102691101 | FLEX COIL N. 6 SERV | ESAOTE SPA | ||
| 30 | 08056304452818 | 9102373101 | SHOULDER COIL N. 7 SERV | ESAOTE SPA | ||
| 31 | 08056304452801 | 9101913101 | FOOT/ANKLE COIL N. 4 SERV | ESAOTE SPA | ||
| 32 | 08056304452795 | 9101912101 | HAND/WRIST COIL N. 3 SERV | ESAOTE SPA | ||
| 33 | 08056304452788 | 9101824201 | Coil for S-scan | KNEE COIL N. 2 SERV | ESAOTE SPA | |
| 34 | 08056304452771 | 9101824101 | KNEE COIL N. 2 SERV | ESAOTE SPA | ||
| 35 | 08056304452764 | 9101819101 | SHOULDER COIL N. 1 SERV | ESAOTE SPA | ||
| 36 | 08056304452757 | 131000800 | CERVICAL COIL N. 14 SERV | ESAOTE SPA | ||
| 37 | 08056304452740 | 9103050001 | SPINE COIL N.10 SERV | ESAOTE SPA | ||
| 38 | 08056304452719 | 131000100 | Coil for S-scan - G-scan Brio | HEAD COIL N.16 | ESAOTE SPA | |
| 39 | 08056304452702 | 130000014 | Coil for S-scan - G-scan Brio | SHOULDER COIL N.20 | ESAOTE SPA | |
| 40 | 08056304452696 | 9101824100 | Coil for G-scan | KNEE COIL N. 2 | ESAOTE SPA | |
| 41 | 08056304452689 | 9103531001 | Coil for G-scan | CERVICAL COIL N. 14 | ESAOTE SPA | |
| 42 | 08056304452672 | 130000016 | Coil for S-scan | XL SPINE COIL N.10 | ESAOTE SPA | |
| 43 | 08056304452634 | 229003500 | TMJ COIL N. 15 | ESAOTE SPA | ||
| 44 | 08056304452542 | 9103531000 | Coil for S-scan | CERVICAL COIL N. 14 | ESAOTE SPA | |
| 45 | 08056304452535 | 9103338000 | Coil for O-scan | ANKLE/FOOT COIL N.3 | ESAOTE SPA | |
| 46 | 08056304452528 | 9103337000 | Coil for O-scan | HAND/WRIST COIL N.2 | ESAOTE SPA | |
| 47 | 08056304452511 | 9103336000 | Coil for O-scan | KNEE COIL N.1 | ESAOTE SPA | |
| 48 | 08056304452474 | 9103050000 | Coil for G-scan / S-scan | SPINE COIL N.10 | ESAOTE SPA | |
| 49 | 08056304452467 | 9102691100 | Coil for G-scan | FLEX COIL N.6 | ESAOTE SPA | |
| 50 | 08056304452450 | 9102373100 | SHOULDER COIL N.7 | ESAOTE SPA |