| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00884838095199 | 712204 | Stationary x-ray system | KPR | System, x-ray, stationary | 2 | DigitalDiagnost C50 | |
| 2 | 00884838082366 | 712201 | 712201 | The DigitalDiagnost C50 is intended for use in generating radiographic images of The DigitalDiagnost C50 is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications. | KPR | System, x-ray, stationary | 2 | DigitalDiagnost C50 |
| 3 | 00884838085015 | 728143 | JAK | System, x-ray, tomography, computed | 2 | Incisive CT | ||
| 4 | 00884838105508 | 728144 | 728144 | The Incisive CT is a Computed Tomography X-Ray System intended to produce cross- The Incisive CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. | JAK | System, X-Ray, Tomography, Computed | 2 | Incisive CT |
| 5 | 00884838096837 | 45980168201X | The Device is designed to be used in conjunction with MR Scanner to produce diag The Device is designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician. | MOS | Coil, Magnetic Resonance, Specialty | 2 | dS MSK M 1.5T | |
| 6 | 00884838064737 | 989701001012 | 712213 | The DuraDiagnost Compact is intended for use in generating radiographic images o The DuraDiagnost Compact is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications. | KPR,MQB | System, x-ray, stationary,Solid state x-ray imager (flat panel/digital imager) | 2 | DuraDiagnost Compact |
| 7 | 00884838095205 | 712203 | Stationary x-ray system | KPR | System, x-ray, stationary | 2 | DuraDiagnost | |
| 8 | 00884838064751 | 712214 | 712214 | The DuraDiagnost is intended for use in generating radiographic images of human The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications. | MQB,KPR | Solid state x-ray imager (flat panel/digital imager),System, x-ray, stationary | 2 | DuraDiagnost |
| 9 | 00884838096820 | 45980168200X | The Device is designed to be used in conjunction with MR Scanner to produce diag The Device is designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician. | MOS | Coil, Magnetic Resonance, Specialty | 2 | dS MSK S 1.5T |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00816589020410 | 20762 | ATS002-R | AtamA 2 Rolling Utility Stand | AtamA™ System | MONTERIS MEDICAL INC |
| 2 | 00816589020397 | 20468 | ATS002 | AtamA 2 Rolling Utility Stand | AtamA™ System | MONTERIS MEDICAL INC |
| 3 | 00816589020380 | 20800 | ATB002-R | AtamA Patient Board | AtamA™ System | MONTERIS MEDICAL INC |
| 4 | 00816589020366 | 20765 | ATB002-IG-R | AtamA Patient Board | AtamA™ System | MONTERIS MEDICAL INC |
| 5 | 00816589020359 | 20764 | ATF103-R | AtamA Head Fixation (3 piece) | AtamA™ System | MONTERIS MEDICAL INC |
| 6 | 00816589020342 | 20763 | ATF102-R | AtamA Head Fixation (2 piece) | AtamA™ System | MONTERIS MEDICAL INC |
| 7 | 00816589020335 | 20760 | ATB002-AC-R | AtamA Patient Board | AtamA™ System | MONTERIS MEDICAL INC |
| 8 | 00816589020328 | 20758 | ATB002-AS-R | AtamA Patient Board | AtamA™ System | MONTERIS MEDICAL INC |
| 9 | 00816589020236 | 20615 | ATF102 | AtamA Head Fixation (2 piece) | AtamA™ System | MONTERIS MEDICAL INC |
| 10 | 00816589020229 | 20609 | ATB002-2 | AtamA Patient Board | AtamA™ System | MONTERIS MEDICAL INC |
| 11 | 00816589020212 | 20607 | ATF103 | AtamA Head Fixation (3 piece) | AtamA™ System | MONTERIS MEDICAL INC |
| 12 | 00816589020205 | 20566 | ATB002-AS | AtamA Patient Board | AtamA™ System | MONTERIS MEDICAL INC |
| 13 | 00816589020199 | 20550 | ATB002-AC | AtamA Patient Board | AtamA™ System | MONTERIS MEDICAL INC |
| 14 | 00816589020175 | 20439 | ATB002-IM | AtamA Patient Board | AtamA™ System | MONTERIS MEDICAL INC |
| 15 | 00816589020090 | 20400 | ATB002 | AtamA Patient Board | AtamA™ System | MONTERIS MEDICAL INC |
| 16 | 00814848020676 | Q7000168 | TxRx Knee 15 Flare MR Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 17 | 00814848020669 | Q7000167 | TxRx Knee 15 Flare MR Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 18 | 00814848020652 | Q7000166 | 8ch Knee SPEEDER Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 19 | 00814848020645 | Q7000160 | 16ch Tx/Rx Knee SPEEDER Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 20 | 00814848020621 | Q7000174 | 1Tx28Rx Knee Coil 7T Clinic | QUALITY ELECTRODYNAMICS LLC | ||
| 21 | 00814848020614 | MAC000110 | Grid Holder CX | QUALITY ELECTRODYNAMICS LLC | ||
| 22 | 00814848020591 | Q7000147 | 16ch Tx/Rx Knee SPEEDER Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 23 | 00814848020577 | Q7000137 | Pediatric 16 | QUALITY ELECTRODYNAMICS LLC | ||
| 24 | 00814848020560 | Q7000126 | Atlas SPEEDER Head/Neck Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 25 | 00814848020553 | Q7000125 | Breast SPEEDER CX Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 26 | 00814848020546 | Q7000198 | Shape Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 27 | 00814848020515 | Q7000188 | 2Tx 28Rx Knee Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 28 | 00814848020508 | Q7000199 | Shape Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 29 | 00814848020485 | Q7000152 | 16ch T/R Hand Wrist Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 30 | 00814848020478 | Q7000075 | 16ch T/R Knee Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 31 | 00814848020461 | Q7000092 | T/R QD Head Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 32 | 00814848020454 | Q7000081 | Wrist SPEEDER Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 33 | 00814848020447 | Q7000076 | Head Neck Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 34 | 00814848020430 | Q7000066 | Medium Torso Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 35 | 00814848020423 | Q7000183 | Contour 24 | QUALITY ELECTRODYNAMICS LLC | ||
| 36 | 00814848020416 | Q7000061 | Pediatric 16 | QUALITY ELECTRODYNAMICS LLC | ||
| 37 | 00814848020409 | Q7000073 | 16ch Foot/Ankle SPEEDER | QUALITY ELECTRODYNAMICS LLC | ||
| 38 | 00814848020393 | Q7000060 | TxRx CP Head Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 39 | 00814848020379 | Q7000059 | TxRx CP Head Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 40 | 00814848020355 | Q7000057 | TxRx Knee 15 Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 41 | 00814848020331 | Q7000056 | TxRx Knee 15 Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 42 | 00814848020317 | Q7000052 | TxRx CP Extremity Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 43 | 00814848020294 | Q7000051 | TxRx 15ch Knee Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 44 | 00814848020270 | Q7000050 | TxRx 15ch Knee Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 45 | 00814848020263 | Q7000049 | Atlas SPEEDER Head-Neck Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 46 | 00814848020256 | Q7000184 | Contour 24 | QUALITY ELECTRODYNAMICS LLC | ||
| 47 | 00814848020249 | Q7000180 | 16ch T/R Hand Wrist Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 48 | 00814848020225 | Q7000037 | Extra Large Knee SPEEDER Coil (Tx/Rx) | QUALITY ELECTRODYNAMICS LLC | ||
| 49 | 00814848020201 | Q7000035 | Atlas SPEEDER Spine Coil | QUALITY ELECTRODYNAMICS LLC | ||
| 50 | 00814848020188 | Q7000032 | 32ch Head SPEEDER Coil | QUALITY ELECTRODYNAMICS LLC |