| Envision Mammography Platform (P080003/S011) | Hologic, Inc. | 2025-11-24 |
| Senographe Pristina 3D (P130020/S005) | GE Healthcare | 2025-11-21 |
| SIR-Spheres Y-90 resin microspheres (P990065/S014) | Sirtex Medical, Inc. | 2025-07-01 |
| SIR-SPHERES (P990065/S017) | Sirtex Medical, Inc. | 2025-04-11 |
| Invenia ABUS Premium, Invenia ABUS Prime (P110006/S011) | GE Healthcare | 2025-02-04 |
| SIR-Spheres Y-90 resin microspheres (P990065/S016) | Sirtex Medical, Inc. | 2025-01-02 |
| TheraSphere (P200029/S010) | Boston Scientific Corporation | 2024-09-24 |
| MAMMOMAT B.brilliant with Tomosynthesis Option (P140011/S008) | Siemens Medical Solutions USA, Inc. | 2024-09-23 |
| Envision Mammography Platform (P080003/S009) | Hologic, Inc. | 2024-07-05 |
| Selenia Dimensions/3Dimensions (P080003/S010) | Hologic, Inc. | 2024-05-29 |
| SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface (P200040/S001) | Delphinus Medical Technologies | 2024-04-11 |
| TheraSphere (P200029/S009) | Boston Scientific Corporation | 2024-04-05 |
| SIR-Spheres Y-90 resin microspheres (P990065/S015) | Sirtex Medical, Inc. | 2024-03-06 |
| TheraSphereTM Y-90 Glass Microspheres System (P200029/S008) | Boston Scientific Corporation | 2024-02-07 |
| TheraSphere (P200029/S006) | Boston Scientific Corporation | 2024-02-06 |
| TheraSphere (P200029/S007) | Boston Scientific Corporation | 2023-12-18 |
| Koning Breast CT, KBCT (Model CBCT1000) (P130025/S004) | Koning Corporation | 2023-10-12 |
| SIR-Spheres Y-90 resin microspheres (P990065/S013) | Sirtex Medical, Inc. | 2023-08-09 |
| TheraSphere (P200029/S005) | Boston Scientific Corporation | 2023-07-26 |
| ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (P160031/S004) | Fujifilm Medical Systems U.S.A, Inc. | 2023-02-13 |
| TheraSphere (P200029/S004) | Boston Scientific Corporation | 2022-12-02 |
| Imagio® Breast Imaging system (P200003/S001) | Seno Medical Instruments, Inc. | 2022-06-17 |
| SIR-Spheres Y-90 resin microspheres (P990065/S012) | Sirtex Medical, Inc. | 2022-04-12 |
| SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface Assembly (P200040) | Delphinus Medical Technologies | 2021-10-06 |
| TheraSphere (P200029/S002) | Boston Scientific Corporation | 2021-08-19 |
| TheraSphere (P200029/S001) | Boston Scientific Corporation | 2021-05-14 |
| Senographe Pristina 3D and SenoClaire (P130020/S004) | GE Healthcare | 2021-03-23 |
| TheraSphere (P200029) | Boston Scientific Corporation | 2021-03-17 |
| Imagio Breast Imaging System (P200003) | Seno Medical Instruments, Inc. | 2021-01-11 |
| ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (P160031/S003) | Fujifilm Medical Systems U.S.A, Inc. | 2020-09-30 |
| MAMMOMAT Revelation with Tomosynthesis Option System (P140011/S007) | Siemens Medical Solutions USA, Inc. | 2020-08-21 |
| MAMMOMAT Revelation with Tomosynthesis Option (P140011/S006) | Siemens Medical Solutions USA, Inc. | 2019-12-10 |
| Aspire Cristalle Digital Breast Tomosynthesis Option (P160031/S002) | Fujifilm Medical Systems U.S.A, Inc. | 2019-10-25 |
| Selenia Dimensions 3D System High Resolution Tomosynthesis (P080003/S008) | Hologic, Inc. | 2019-10-24 |
| Logicon Caries Detection Software (P980025/S004) | Carestream Dental, LLC | 2019-09-05 |
| ASPIRE Cristalle Breast Tomosynthesis System (P160031/S001) | Fujifilm Medical Systems U.S.A, Inc. | 2019-02-08 |
| Invenia ABUS (Automated Breast Ultrasound System) 2.0 (P110006/S010) | GE Healthcare | 2018-08-24 |
| Selenia Dimensions / 3Dimensions (P080003/S007) | Hologic, Inc. | 2018-06-22 |
| Invenia ABUS 2.0 Automated Breast Ultrasound System (P110006/S009) | GE Healthcare | 2018-05-11 |
| Selenia Dimensions/3Dimensions 3D System (P080003/S006) | Hologic, Inc. | 2018-03-23 |
| Senographe Pristina 3D (P130020/S003) | GE Healthcare | 2017-12-28 |
| QVCAD System (Version 3.3) (P150043/S001) | Qview Medical, Inc. | 2017-12-14 |
| Koning Breast CT, KBCT (P130025/S003) | Koning Corporation | 2017-10-24 |
| Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option (P140011/S005) | Siemens Medical Solutions USA, Inc. | 2017-09-29 |
| Invenia ABUS Autoated Breast Ultrasound System (P110006/S008) | GE Healthcare | 2017-09-07 |
| Selenia Dimensions 3D System. (P080003/S005) | Hologic, Inc. | 2017-05-23 |
| Invenia ABUS - Automated Breast Ultrasound System (P110006/S007) | GE Healthcare | 2017-05-01 |
| 3Dimensions (P080003/S004) | Hologic, Inc. | 2017-04-20 |
| PowerLook® Tomo Detection Software (P160009) | Icad, Inc. | 2017-03-24 |
| SIR-Spheres microspheres (P990065/S009) | Sirtex Medical, Inc. | 2017-03-24 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S003) | Siemens Medical Solutions USA, Inc. | 2017-03-23 |
| SENOGRAPHE PRISTINA 3D (P130020/S002) | GE Healthcare | 2017-03-03 |
| SIR-SPHERES MICROSPHERES (P990065/S010) | Sirtex Medical, Inc. | 2017-01-18 |
| M-VU ALGORITHM ENGINE (P100005/S007) | Icad, Inc. | 2017-01-11 |
| ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION (P160031) | Fujifilm Medical Systems U.S.A, Inc. | 2017-01-10 |
| SENOCLAIRE (P130020/S001) | GE Healthcare | 2017-01-05 |
| QVCAD SYSTEM (P150043) | Qview Medical, Inc. | 2016-11-09 |
| KONING BREAST CT (MODEL CBCT 1000) (P130025/S002) | Koning Corporation | 2016-10-06 |
| SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P080003/S003) | Hologic, Inc. | 2016-07-07 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S001) | Siemens Medical Solutions USA, Inc. | 2016-05-12 |
| IMAGE CHECKER, IMAGE CHECKER LICENSE (P970058/S027) | Hologic, Inc. | 2016-04-26 |
| MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION (P140011/S002) | Siemens Medical Solutions USA, Inc. | 2016-01-13 |
| LOGICON CARIES DETECTOR (P980025/S003) | Carestream Dental, LLC | 2015-12-10 |
| PARASCRIPT (R) ACCUDETECT (R) (P120004/S001) | Parascript, LLC | 2015-10-16 |
| INVENIA ABUS -- AUTOMATED BREAST ULTRASOUND SYSTEM (P110006/S006) | GE Healthcare | 2015-10-15 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011) | Siemens Medical Solutions USA, Inc. | 2015-04-21 |
| INVENIA ABUS- AUTOMATED BREAST ULTRASOUND SYSTEM (P110006/S005) | GE Healthcare | 2015-04-13 |
| M-VU ALGORITHM ENGINE (P100005/S005) | Icad, Inc. | 2015-03-02 |
| SIR-SPHERES MICROSPHERES (P990065/S008) | Sirtex Medical, Inc. | 2015-02-27 |
| KONING BREAST CT (MODEL CBCT1000) (P130025) | Koning Corporation | 2015-01-14 |
| INVENIA ABUS-AUTOMATED BREAST ULTRASOUND SYSTEM (P110006/S004) | GE Healthcare | 2014-11-24 |
| SIR-SPHERE MICROSPHERES (P990065/S007) | Sirtex Medical, Inc. | 2014-10-09 |
| SENOCLAIRE (P130020) | GE Healthcare | 2014-08-26 |
| LOGICON CARIES DETECTOR (P980025/S002) | Carestream Dental, LLC | 2014-07-22 |
| M-VU ALGORITHM ENGINE (P100005/S004) | Icad, Inc. | 2014-06-06 |
| INVENIA ABUS (P110006/S003) | GE Healthcare | 2014-03-20 |
| INVENIA ABUS (P110006/S002) | GE Healthcare | 2014-02-11 |
| IMAGE CHECKER CAD (P970058/S026) | Hologic, Inc. | 2014-02-10 |
| M-VU ALGORITHM ENGINE (P100005/S003) | Icad, Inc. | 2013-12-02 |
| PARASCRIPT ACCUDETECT 6.1.0 (P120004) | Parascript, LLC | 2013-08-22 |
| M-VU ALGORITHM ENGINE (P100005/S002) | Icad, Inc. | 2013-06-19 |
| SECONDLOOK DIGITAL (P010038/S017) | Icad, Inc. | 2013-06-19 |
| SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM (P110006/S001) | GE Healthcare | 2013-06-17 |
| SELENIA DIMENSIONS 3D SYSTEM (P080003/S001) | Hologic, Inc. | 2013-05-16 |
| SECONDLOOK DIGITAL V7.2 CAD (P010038/S016) | Icad, Inc. | 2012-11-09 |
| M-VU ALGOIRITHM ENGINE (P100005/S001) | Icad, Inc. | 2012-10-01 |
| IMAGECHECKER CAD (P970058/S025) | Hologic, Inc. | 2012-09-21 |
| SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM) (P110006) | GE Healthcare | 2012-09-18 |
| SIR-SPHERES (P990065/S006) | Sirtex Medical, Inc. | 2012-07-17 |
| CLEAREAD DETECT (P000041/S011) | Riverain Medical Group | 2012-02-27 |
| BREAST COMPANION SOFTWARE SYSTEM (P100007) | Almen Laboratories, Inc. | 2012-02-10 |
| M-VU ALGORITHM ENGINE (P100005) | Icad, Inc. | 2012-01-23 |
| CLEARREAD DETECT (P000041/S010) | Riverain Medical Group | 2011-11-08 |
| SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P080003) | Hologic, Inc. | 2011-02-11 |
| SECONDLOOK (SL) CAD (P010038/S013) | Icad, Inc. | 2010-12-07 |
| KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE (P080018/S001) | Carestream Health, Inc. | 2010-12-01 |
| HOLOGIC SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S019) | Hologic, Inc. | 2010-11-16 |
| SIEMENS MAMMOMAT INSPIRATION FULL - FIELD DIGITAL MAMMOGRAPHY SYSTEM (P030010/S006) | Siemens Medical Solution | 2010-11-05 |
| GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM (P990066/S037) | GE Healthcare | 2010-11-05 |
| KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY (P080018) | Carestream Health, Inc. | 2010-11-03 |