No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00866562000236 | v5 | 91309 | Standard Imaging PIPSpro Software is a stand alone software medical device used Standard Imaging PIPSpro Software is a stand alone software medical device used for QA checks of imaging systems used with radiation therapy systems. | IYE | Accelerator, Linear, Medical | 2 | Standard Imaging PIPSpro Software |
2 | 00866562000205 | 92260 | 92260 | Standard Imaging DoseView 3D is a medical device intended for performing water p Standard Imaging DoseView 3D is a medical device intended for performing water phantom based commissioning and QA measurements on radiation therapy systems. | IYE | Accelerator, Linear, Medical | 2 | Standard Imaging DoseView 3D |
3 | 00866562000243 | v1 | 91350 | Standard Imaging Adaptivo Software is a stand alone software medical device used Standard Imaging Adaptivo Software is a stand alone software medical device used for QA checks of comparative and cumulative dose received during radiation treatment from radiation therapy systems. | IYE | Accelerator, Linear, Medical | 2 | Standard Imaging Adaptivo |
4 | 00866562000229 | v3 | 91326 | Standard Imaging IMSure QA Software is a stand alone software medical device use Standard Imaging IMSure QA Software is a stand alone software medical device used for monitor unit secondary checks and IMRT treatment plan secondary checks of radiation treatment plans from radiation therapy systems. | IYE | Accelerator, Linear, Medical | 2 | Standard Imaging IMSure QA Software |
5 | 00866562000267 | 91330 | 91330 | Standard Imaging LinacView Software is a stand alone software medical device use Standard Imaging LinacView Software is a stand alone software medical device used for logfile analysis of radiation therapy systems. | IYE | Accelerator, Linear, Medical | 2 | Standard Imaging LinacView Software |
6 | 00866562000212 | 90008 | 90008 | Standard Imaging HDR 1000 Plus is a medical device intended as a transducer for Standard Imaging HDR 1000 Plus is a medical device intended as a transducer for brachytherapy radiation QA measurements. | KPT | Calibrator, Dose, Radionuclide | 2 | Standard Imaging HDR 1000 Plus |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 08719324589048 | 0202020117 | Dose Calibrator for the measuring of radiopharmaceutical activity in syringes and vials | VDC606 | COMECER NETHERLANDS B.V. | |
2 | 08719324589024 | 0203010016 | Dose Calibrator Read Out Unit | IBC-Lite | COMECER NETHERLANDS B.V. | |
3 | 08719324589017 | 0202020091 | Measuring unit for the dose calibrator | VIK203 | COMECER NETHERLANDS B.V. | |
4 | 08719324589000 | 0202020001 | Measuring unit for the dose calibrator | VIK202 | COMECER NETHERLANDS B.V. | |
5 | 00866562000250 | 90009 | 90009 | Standard Imaging IVB 1000 is a medical device intended as a transducer for brach Standard Imaging IVB 1000 is a medical device intended as a transducer for brachytherapy radiation QA measurements. | Standard Imaging IVB 1000 Well Chamber | STANDARD IMAGING INC. |
6 | 00866562000212 | 90008 | 90008 | Standard Imaging HDR 1000 Plus is a medical device intended as a transducer for Standard Imaging HDR 1000 Plus is a medical device intended as a transducer for brachytherapy radiation QA measurements. | Standard Imaging HDR 1000 Plus | STANDARD IMAGING INC. |
7 | 00859942006089 | CRC-PC Smart Chamber RPh Chamber | 5130-20254 | Radioisotope Dose Calibrator | Capintec Dose Calibrator | CAPINTEC, INC. |
8 | 00859942006072 | CRC-PC Smart Chamber HL Chamber | 5130-20253 | Radioisotope Dose Calibrator | Capintec Dose Calibrator | CAPINTEC, INC. |
9 | 00859942006065 | CRC-77tHR | 5130-30261 | Radioisotope Dose Calibrator | Capintec Dose Calibrator | CAPINTEC, INC. |
10 | 00859942006058 | CRC-25W | Radioisotope Dose Calibrator | Capintec Dose Calibrator | CAPINTEC, INC. | |
11 | 00859942006041 | CRC-25PET | Radioisotope Dose Calibrator | Capintec Dose Calibrator | CAPINTEC, INC. | |
12 | 00859942006034 | CRC-25R | Radioisotope Dose Calibrator | Capintec Dose Calibrator | CAPINTEC, INC. | |
13 | 00859942006027 | CRC-55tW | Radioisotope Dose Calibrator | Capintec Dose Calibrator | CAPINTEC, INC. | |
14 | 00859942006010 | CRC-55tPET | Radioisotope Dose Calibrator | Capintec Dose Calibrator | CAPINTEC, INC. | |
15 | 00859942006003 | CRC-55tR | Radioisotope Dose Calibrator | Capintec Dose Calibrator | CAPINTEC, INC. | |
16 | 00813787020761 | XX1526 | Seeds for IsoStrand - STERILE | TheraSeed | THERAGENICS CORPORATION | |
17 | 00813787020754 | XX1525 | Seeds for IsoCartridge - STERILE | TheraSeed | THERAGENICS CORPORATION | |
18 | 00813787020297 | XX1526i | Seeds for IsoStrand - STERILE | I-Seed Agx100 | THERAGENICS CORPORATION | |
19 | 00813787020280 | XX1525i | Seeds for IsoCartridge - STERILE | I-Seed Agx100 | THERAGENICS CORPORATION | |
20 | 00718175003350 | 086-335 | 086-335 | Atomlab 400 Dose Calibrator | Atomlab Dose Calibrator | BIODEX MEDICAL SYSTEMS, INC. |
21 | 00718175003343 | 086-331 | 086-331 | Atomlab Wipe Test Counter | Atomlab Wipe Test Counter | BIODEX MEDICAL SYSTEMS, INC. |
22 | 00718175003329 | 086-332 | 086-332 | Atomlab 500 Plus Dose Calibrator and Wipe Test System | Atomlab 500 Plus | BIODEX MEDICAL SYSTEMS, INC. |
23 | 00718175003305 | 086-330 | 086-330 | Atomlab 500 Dose Calibrator | Atomlab 500 Dose Calibrator | BIODEX MEDICAL SYSTEMS, INC. |